How Supplied; Handling And Storage - Boston Scientific AMS 800 Mode D'emploi

Table 6. Adverse Events in Patients Studied
Complication
Bladder injury
Vaginal injury
Cuff erosion
Infection/erosion
Device fluid leak
Incisional hernia
Urinary retention
Urethral injury
Urinary urgency
Labia hematoma
Infection
Pelvic abcess
Early post-operative morbidity
Pressure atrophy at cuff site
Cutaneous erosion
Bothered by device
Pulmonary embolus
Enterocutaneous fistula
Phlebitis
Upper urinary tract deterioration
Superficial wound dehiscence
Device malfunction
Device displacement
Device damage - unrelated prodedure
Wound seroma
Pump erosion
Sphincter related problem
Loose cuff
Success Rates
Patient success rates were reported and analyzed. For those defining clinical
success , rates of success were categorized as follows:
8,10,11,12,13,18,19,22,23
• Fully and socially continent = 0-1 pad used per day
• Occasional incontinence = Consistent use of 1-2 pads per day
• Fair/improved continence = Use of 3 pads per day
• Not improved = Use of more than 3 pads per day
Success rates are summarized in Table 7.
Table 7. Success Rates
Success Criteria
Fully and socially continent
Occasional incontinence
Fair/improved
Not improved
Patient Information Form (PIF) Analysis
A retrospective analysis was performed for female patients implanted (n=637) with the
AMS 800 AUS during the five-year period 2000-2005. The analysis examined Patient
™
Information Form (PIF) data sent to the manufacturer by the implanting physician for
original implants and revision surgeries. Of the 637 female patients implanted during the
period studied, 76 patients had undergone a total of 88 revision surgeries (1.16 revisions
per patient). There were a total of 121 reported reasons for revisions. Note that more
than one reason may be listed for the same revision. The data in Table 8 presents the
reported reasons for revision and the percentage of each reason for revision.
This analysis did not include AMS 800 AUS devices treated with InhibiZone
Percentage Reference
5.8% 8,14, 17, 23
4.2% 8,10, 14, 17, 19
3.4% 9, 12, 13, 16, 19, 23
3.3% 7
2.8% 8, 9, 15, 18, 19, 21, 22, 23
1.5% 8
1.3% 8, 22
1.2% 8, 10, 17
1.1% 8, 12
1.0% 8, 20
0.6% 7, 10, 14, 16, 23
0.4% 22
0.4% 8
0.3% 23
0.3% 10
0.3% 8
0.1% 7
0.1% 7
0.1% 8
0.1% 19
0.1% 22
0.1% 7, 8, 19, 22, 23
0.1% 9
0.1% 12
0.1% 15
0.1% 19
0.1% 16
0.1% 21, 22
% patients
86.9
4.4
4.3
7.1
.
™
Table 8. PIF Analysis Revision Data
Reason for revision
Incontinence
Not specified
Infection
Fluid loss
Erosion
Other medical condition
Device out of specification/malfunction
Improper size of device
Other*
Urinary retention
Pain
*Other includes: hematoma, device migration/malposition, patient dissatisfaction.

HOW SUPPLIED

The components of the AMS 800 AUS and Accessory Kit are supplied sterile.
• Do not use if package is open or damaged.
• Do not use if labeling is incomplete or illegible.
• Do not use if the device is past the "Use By" date.

Handling and Storage

InhibiZone treated components: Keep dry and protect from light. Recommended storage
at 25°C (77°F); excursions permitted to 15°C-40°C (59°F-104°F).
Non-InhibiZone treated components: Store in a cool, dry, dark place.
Supplemental Surgical Tools
The following BSC surgical tools which are used to help facilitate implantation of the
AMS 800 AUS may be ordered separately.
Non-Sterile Tools
The following tools are provided non-sterile and must be sterilized before use. For
reprocessing information, refer to the instructions manual provided with the tools.
• Quick Connect Assembly Tool
In order to use the Quick Connect Window Connectors in the AMS 800 Accessory
Kit, the Quick Connect Assembly Tool must be ordered. This is a reusable stainless
steel instrument used to close the connectors (Figure 12).
Figure 12. Quick Connect Assembly Tool
• Insertion Package (2 stainless steel Tubing Passers)
Two curved tubing passers are used to route the tubing of the components from
incision site to incision site. The machined end of the passer provides a snug fit in
the tubing lumen (Figure 13).
Figure 13. Tubing Passers
9
% revisions
19.8
19.8
13.2
11.6
10.7
8.3
5.8
3.3
3.3
1.7
1.7
Black (K) ∆E ≤5.0