Adverse Events - Boston Scientific AMS Ambicor Mode D'emploi

ADVERSE EVENTS

A clinical trial was conducted to determine the safety and effectiveness of the AMS
Ambicor Inflatable Penile Prosthesis. A total of 179 patients were implanted with
™
follow-up out to 18 months or longer for 141 patients. There were four patient deaths
during the course of the trial. No deaths that occurred during the duration of the clinical
study were attributed to the device implantation or use.
The Adverse Device Events (ADE), detailed in Tables 5 and 6, were noted during the
duration of this clinical trial for all enrolled patients.
Table 5: AMS Ambicor Penile Prosthesis Clinical Trial Device Related Adverse Events
ADE # Patients
Urogenital Pain (Typically 38 (21.2%)
Associated with Healing Process)
Patient Dissatisfaction (With 22 (12.3%)
Length, Ability to Use and
Nonspecific Reasons)
Mechanical Malfunction
Penile Sensation Change
Urogenital Hematoma
Urogenital Edema
Infection/Device Infection
Auto-inflation
Penile Curvature
Abnormal Ejaculation
Application Site Reaction (Wound
Separation, Delay in Cutaneous
Closure)
Phimosis/Paraphimosis
Post-Operative Bleeding
Seroma
Urinary retention
Urogenital Ecchymosis
Adhesion
Auto-deflation
Nocturia
Penile Rash
Renal Failure
Urethral Laceration
Urinary Tract Infection
Urination Impaired
Urogenital Erythema
Other Urogenital 23 (12.8%)
Other Non-urogenital
* Percentages based on total number of patients implanted (n=179).
The following "other" urogenital adverse events each occurred in one patient: abnormal sexual function, allergic
reaction, BPH, burning urination, crossover from left to right corpora, device migration, dribbling, dysuria,
epididymitis, extrusion, incontinence, induration in penile area, lower urinary tract symptoms, malposition,
meatal excoriation, micro-hematuria, penile scar tissue, prerenal azotemia, scab on corpora, soft glans, tunica
perforation, urosepsis, wound dehiscence and wound infection.
# Events Mean Onset time in
(%*) Days (Range in Days)
41 83 (0 – 548)
25 269 (0 – 1105)
11 (6.1%) 11 394 (0 – 1508)
11 (6.1%) 11 266 (10 – 573)
9 (5.0%) 9 9 (2 – 34)
8 (4.5%) 9 9 (0 – 29)
6 (3.4%) 8 207 (32 – 606)
4 (2.2%) 4 110 (27 – 224)
4 (2.2%) 4 323 (0 – 999)
3 (1.7%) 3 256 (40 – 487)
3 (1.7%) 3 26 (0 – 46)
3 (1.7%) 3 21 (3 – 38)
3 (1.7%) 3 4 (2 – 6)
3 (1.7%) 3 242 (34 – 596)
3 (1.7%) 3 121 (0 – 361)
3 (1.7%) 3 123 (6 – 351)
2 (1.1%) 2 42 (34 – 50)
2 (1.1%) 2 486 (212 – 760)
2 (1.1%) 2 245 (105 – 385)
2 (1.1%) 2 272 (43 – 501)
2 (1.1%) 2 476 (396 – 555)
2 (1.1%) 2 1 (0 – 2)
2 (1.1%) 2 283 (4 – 561)
2 (1.1%) 2 225 (64 – 385)
2 (1.1%) 2 193 (13 – 373)
24 97 (0 – 727)
10 (5.6%) 14 176 (0 – 556)
Table 6. Resolution of Device Related Adverse Events
Urogenital Pain 38 (21.2 %)
Patient 22 (12.3 %)
Dissatisfaction
Mechanical 11 (6.1 %)
Malfunction
Penile Sensation 11 (6.1 %)
Change
Urogenital 9 (5.0 %)
Hematoma
Urogenital Edema 8 (4.5 %)
Infection/Device 8 (4.5 %)
Infection
Auto-inflation 4 (2.2 %)
Penile Curvature 4 (2.2 %)
Abnormal Ejaculation 3 (1.7 %)
Application Site 3 (1.7 %)
Reaction
Phimosis/Paraphimosis 3 (1.7 %)
Post-Operative 3 (1.7 %)
Bleeding
Seroma 3 (1.7 %)
Urinary retention 3 (1.7 %)
Urogenital Ecchymosis 3 (1.7 %)
Adhesion 2 (1.1 %)
Auto-deflation 2 (1.1 %)
Nocturia 2 (1.1 %)
Penile Rash 2 (1.1 %)
Renal Failure 2 (1.1 %)
Urethral Laceration 2 (1.1 %)
Urinary Tract Infection 2 (1.1 %)
Urination Impaired 2 (1.1 %)
Urogenital Erythema 2 (1.1 %)
** Other methods of resolution consist of standard medical treatments.
A total of 14 patients underwent revision surgeries in the study. Information on device
revisions is described in the Clinical Studies section.
The following events occurred during this clinical study but were classified by the
Investigators as not related to the device or the implantation surgery: urethral stricture
(9 cases), prostate cancer (4 cases), BPH (3 cases), incontinence (3 cases), urinary
retention (3 cases), urinary tract infection (3 cases), abnormal prostate exam/PSA
(2 cases), abnormal sexual function (2 cases), balanitis (2 cases), hematuria (2 cases),
pain (2 cases), renal calculus (2 cases), abnormal ejaculation (1 case), bladder instability
(1 case), bladder spasms (1 case), blood in urine (1 case), dysuria (1 case), edema (1 case),
epididymal cyst (1 case), eroded artificial sphincter (1 case), erythema (1 case), infection
(1 case), inguinal hernia (1 case), nocturia (1 case), prostate nodule (1 case), prostatitis
(1 case), pyuria (1 case), renal colic (1 case), renal insufficiency (1 case), testicular cyst
(1 case), testicular hydrocele (1 case), trichomonas (1 case), urethral mucosal atrophy
(1 case), urination impaired (1 case), urgency (1 case), and urosepsis (1 case).
The following adverse events may be associated with this product: abscess, bleeding,
erosion, excessive fibrous capsular growth, exposure to biohazardous material, genital
changes, granulomas, hemorrhage, immune-related connective tissue disorders,
improper size, inguinal hernia, ischemia, necrosis, pain (which may be prolonged or
severe), perforation or injury of bladder, corpus cavernosum, nerve, tunica, or urethra,
prolonged procedure, Super Sonic Transporter (SST) (as a result of improper sizing),
ulceration, unretrieved device fragment, vascular compromise, and ventral chordee.
5
41 3 9 1 29
25 3 3 3 16 14
11 7 0 1 3
11 0 2 0 10
9 0 1 3 6
9 0 2 2 5
8 6 1 0 1
4 0 0 0 4
4 2 0 0 2
3 0 1 0 2
3 0 1 0 2
3 1 2 0 0
3 0 0 0 3
3 0 0 1 2
3 1 1 2 0
3 0 0 0 3
2 1 0 0 1
2 0 0 1 1
2 0 1 0 1
2 0 1 1 0
2 0 0 1 1
2 0 0 1 1
2 0 2 0 0
2 0 1 1 0
2 0 2 0 0
Black (K) ∆E ≤5.0
8
1
4
0
0
1
2
2
1
0
0
0
0
1
0
0
0
2
1
1
0
0
2
0