Merit Medical Embosphere Mode D'emploi page 9

Event
Abdominal pain lower
Abdominal pain upper
Abdominal rigidity
Anorectal discomfort
Constipation
Dental necrosis
Diarrhea
Hematochezia
Hemorrhoids
Nausea
Vomiting
General disorders and administration site
conditions
Catheter site inflammation
Chest pain
Chills
Facial pain
Local swelling
Pain
Pyrexia
Suprapubic pain
Infections and infestations
Cellulitis
Localized infection
Nasopharyngitis
Sepsis
Urinary tract infection
Injury, poisoning and procedural complications
Bladder injury
Fall
Post prostatic artery embolization syndrome
Procedural pain
Pubic bone injury
Rectal injury
Investigations
Blood urine present
Musculoskeletal and connective tissue disorders
Arthralgia
Chest wall mass
Flank pain
Groin pain
Muscle spasms
Musculoskeletal chest pain
Musculoskeletal discomfort
Musculoskeletal pain
Pain in extremity
Nervous system disorders
Dizziness
Headache
Sciatica
Renal and urinary disorders
Bladder discomfort
Bladder spasm
Dysuria
Hematuria
Micturition urgency
Pollakuria
Renal failure acute
Terminal dribbling
Urethral pain
Urethral trauma
Urinary incontinence
Urinary retention
Urinary straining
Reproductive system and breast disorders
PAE
1 (0.3%)
1 (0.3%)
2 (0.7%)
1 (0.3%)
4 (1.4%)
1 (0.3%)
2 (0.7%)
14 (4.9%)
1 (0.3%)
5 (1.7%)
1 (0.3%)
18 (6.3%)
1 (0.3%)
1 (0.3%)
1 (0.3%)
1 (0.3%)
3 (1.0%)
1 (0.3%)
8 (2.8%)
2 (0.7%)
13 (4.5%)
1 (0.3%)
1 (0.3%)
2 (0.7%)
1 (0.3%)
8 (2.8%)
217 (75.9%)
1 (0.3%)
1 (0.3%)
212 (74.1%)
1 (0.3%)
1 (0.3%)
1 (0.3%)
1 (0.3%)
1 (0.3%)
11 (3.8%)
1 (0.3%)
1 (0.3%)
1 (0.3%)
2 (0.7%)
1 (0.3%)
1 (0.3%)
1 (0.3%)
1 (0.3%)
2 (0.7%)
4 (1.4%)
2 (0.7%)
1 (0.3%)
1 (0.3%)
65 (22.7%)
3 (1.0%)
5 (1.7%)
22 (7.7%)
10 (3.5%)
6 (2.1%)
2 (0.7%)
1 (0.3%)
1 (0.3%)
2 (0.7%)
1 (0.3%)
2 (0.7%)
9 (3.1%)
1 (0.3%)
36 (12.6%)
9
Event
Decreased ejaculatory volume
Epididymal cyst
Hematospermia
Pelvic pain
Penile burning sensation
Penile pain
Perineal pain
Prostatitis
Testicular pain
Varicocele
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
Dyspnoea
Nasal congestion
Pulmonary mass
Skin and subcutaneous tissue disorders
Skin discoloration
Surgical and medical procedures
Arthroscopic surgery
Vascular disorders
Hematoma
Hypertension
The most common adverse event was Post-PAE Syndrome.
REFERENCES
UFE Specific References
1. Spies JB, Cornell C, Worthington-Kirsch R, Lipman JC, Benenati JF, Long-term
Outcome from Uterine Fibroid Embolization with Tris-acryl Gelatin Microspheres:
Results of a Multicenter Study. J Vasc Interv Radiol, 2007; 18:203-207.
2. Spies JB, Benenati JF, Worthington-Kirsch RL, Pelage JP, Initial experience
with use of tris-acryl gelatin microspheres for uterine artery embolization for
leiomyomata, J Vasc Interv Radiol, 2001;12:1059-1063.
3. Spies JB, Spector A, Roth AR, Baker CM, Mauro L, Murphy-Skrynarz K,
Complications after uterine artery embolization for leiomyomas. Obstet Gynecol,
2002;100:873-80.
4. Goldberg J, Pereira L, and Berghella V, Pregnancy After Uterine Artery
Embolization. Obstet Gynecol, 2002;100(5):869-872.
5. Scialli A, Alternatives to hysterectomy for benign conditions. Int J Fert Women's
Med, 1998;43(4): 186-91.
6. Nikolic B, Spies JB, Campbell L, Walsh SM, Abbara S, Lundsten MJ, Uterine artery
embolization: reduced radiation with refined technique. J Vasc Interv Radiol,
2001;12(1):39-44.
7. Worthington-Kirsch R, G Popky, F Hutchins, Uterine arterial embolization for the
management of leiomyomas: Quality-of-life assessment and clinical response.
Radiol, 1998;208: 625-629.
8. Pelage JP, Le Dref O, Soyer P, Kardache M, Dahan H, Abitbol M, Merland JJ,
Ravina JH, Rymer R, Fibroid-related menorrhagia: treatment with superselective
embolization of the uterine arteries and mid-term follow-up. Radiology,
2000;215(2):428-431.
9. Ware J, Kosinski M, Keller S. SF-12: how to score the SF-12 physical and mental
health summary scales. 3rd ed. Lincoln, RI: Quality Metric; 1998.
PAE Specific References
1. Amouyal G, Thiounn N, Pellerin O, et al. Clinical results after prostatic artery
embolization using the PErFecTED technique: a single-center study. Cardiovasc
Intervent Radiol 2015; 39(3):367-75. DOI 10.1007/s00270-015-1267-0.
2. Antunes AA, Carnevale FC, da Motta Leal Filho JM, et al. Clinical, laboratorial,
and urodynamic findings of prostatic artery embolization for the treatment of
urinary retention related to benign prostatic hyperplasia. A prospective single-
center pilot study. Cardiovasc Intervent Radiol 2013; 36(4):978-86. DOI 10.1007/
s00270-013-0611-5.
3. Bhatia S, Kava B, Pereira K, et al. Prostate artery embolization for giant
prostatic hyperplasia. J Vasc Interv Radiol 2015; 26(10):1583-5. DOI 10.1016/j.
jvir.2015.05.024.
4. Camara-Lopes G, Mattedi R, Antunes AA, et al. The histology of prostate tissue
following prostatic artery embolization for the treatment of benign prostatic
hyperplasia. Int Braz J Urol 2013; 39(2):222-7. DOI 10.1590/S1677-5538.
IBJU.2013.02.11.
5. Carnevale FC, Antunes AA, da Motta Leal Filho JM, et al. Prostatic artery
embolization as a primary treatment for benign prostatic hyperplasia:
preliminary results in two patients. Cardiovasc Intervent Radiol 2010; 33(2):355-
61. DOI 10.1007/s00270-009-9727-z.
6. Carnevale FC, da Motta Leal Filho JM, Antunes AA, et al. Midterm follow-up
after prostate embolization in two patients with benign prostatic hyperplasia.
Cardiovasc Intervent Radiol 2011; 34(6):1330-3. DOI 10.1007/s00270-011-0136-8.
7. Carnevale FC, da Motta Leal Filho JM, Antunes AA, et al. Quality of life and clinical
symptom improvement support prostatic artery embolization for patients with
acute urinary retention caused by benign prostatic hyperplasia. J Vasc Interv
Radiol 2013; 24(4):535-42. DOI 10.1016/j.jvir.2012.12.019.
PAE
14 (4.9%)
1 (0.3%)
12 (4.2%)
3 (1.0%)
1 (0.3%)
1 (0.3%)
1 (0.3%)
1 (0.3%)
1 (0.3%)
1 (0.3%)
6 (2.1%)
2 (0.7%)
2 (0.7%)
1 (0.3%)
1 (0.3%)
2 (0.7%)
2 (0.7%)
1 (0.3%)
1 (0.3%)
2 (0.7%)
1 (0.3%)
1 (0.3%)