INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2022-10371
- Event Type
- Injury
- Date Received
- June 17, 2022
- Date of Event
- May 17, 2022
- Report Date
- August 10, 2022
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 10888628033115
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCE NOTED. THE EVENT OF INFECTION (LATE ONSET) IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: RUPTURE AND INFECTION (LATE ONSET).
DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF PAIN, CAPSULAR CONTRACTURE, RUPTURE, AND INFECTION (LATE ONSET), WAS RECEIVED ON (B)(6) 2022, WITH LOT NUMBER 3151886. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED, WEIGHT TO THE SPEC, TWO OPENINGS ON RADIUS AND POSTERIOR, RED PARTICLES ON THE SHELL, CREASE FLAT, AND MISSING A PIECE OF SHELL (0-25%). A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED, STRIATED BROKEN ON RADIUS AND TWO STRIATED OPENINGS ON RADIUS AND POSTERIOR. BASED ON THE DEVICE ANALYSIS, THE FINAL ASSESSMENT IS: STRIATED BROKEN ON RADIUS ASSESSED, AS SURGICAL DAMAGE. TWO STRIATED OPENINGS ON RADIUS AND POSTERIOR ASSESSED, AS SURGICAL DAMAGE.
FI SUMMARY: WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, THERE IS ENOUGH EVIDENCE TO SUPPORT THAT DEVICE SERIAL NUMBER (B)(6) WAS MANUFACTURED UNDER CONTROLLED CONDITIONS IN ACCORDANCE WITH ABBVIE¿S PROCEDURES. SEAL STRENGTH RESULTS WERE ACCEPTABLE. ENVIRONMENTAL MONITORING RESULTS WERE FOUND TO BE ACCEPTABLE, AND THEY CONFIRMED THAT THERE WAS NOT AN ADVERSE IMPACT ON ENVIRONMENTAL CONDITIONS, DEVICE QUALITY OR PERFORMANCE. THE STERILIZATION RUN 30029406 IS NOT RELATED TO ANY ADDITIONAL COMPLAINT INFECTION RECORD REPORTED AS OF TODAY. DURING THE TREND REVIEW OF ALL INFECTION COMPLAINTS FOR GEL BREAST IMPLANTS FOR THE PERIOD OF (B)(6)2020 THROUGH (B)(6)2022, WAS NOTED AN OUTLIER IN JANUARY 2021. AN ADDITIONAL ANALYSIS WAS PERFORMED TO DETERMINE ANY PATTERN OR ANY SIMILARITIES RELATION BETWEEN PRS INVOLVED. IT WAS FOUND THAT SOME STERILIZERS WERE INVOLVED IN MORE THAN ONE OCCASION, HOWEVER, CALIBRATIONS AND MAINTENANCE OF THE EQUIPMENT INVOLVED WERE REVIEWED AND IT WAS DETERMINED THAT THEY WERE PERFORMED ON TIME AND MET SPECIFICATIONS. IN ADDITION, ALL THE RECORDS INVOLVED IN THIS MONTH WERE REVIEWED AND NO ISSUES WERE FOUND ASSOCIATED TO EITHER EVENT. GIVEN THE FACT THAT THE CAUSE OF THE INFECTION CANNOT BE SPECIFICALLY ASSOCIATED TO THE MANUFACTURING PROCESS, AND THERE IS NOT AN ADVERSE TREND FOR THIS TYPE OF EVENT NO CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS TIME.
PATIENT REPORTED A LEFT SIDE PAIN AND CAPSULAR CONTRACTURE BAKER GRADE II. LATER, HEALTHCARE PROFESSIONAL REPORTED RUPTURE DISCOVERED DURING SURGERY. PATIENT ADDITIONALLY REPORTED "INFECTION FOUND AT THE TIME OF EXPLANT SURGERY". THE DEVICE HAS BEEN EXPLANTED.
PATIENT REPORTED, A LEFT SIDE PAIN. AND CAPSULAR CONTRACTURE, BAKER GRADE II. LATER, HEALTHCARE PROFESSIONAL REPORTED, RUPTURE. DISCOVERED, DURING SURGERY. PATIENT ADDITIONALLY REPORTED, "INFECTION FOUND AT THE TIME OF EXPLANT SURGERY". THE DEVICE HAS BEEN EXPLANTED.
PATIENT REPORTED A LEFT SIDE PAIN AND CAPSULAR CONTRACTURE BAKER GRADE II. LATER, HEALTHCARE PROFESSIONAL REPORTED RUPTURE DISCOVERED DURING SURGERY. PATIENT ADDITIONALLY REPORTED "INFECTION FOUND AT THE TIME OF EXPLANT SURGERY". THE DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1398914 | INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | SSF-325 | 3151886 | 10888628033115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female | Required Intervention |