MENTOR SMOOTH ROUND MODERATE PROFILE
Report
- Report Number
- 1645337-2018-07628
- Event Type
- Injury
- Date Received
- December 28, 2018
- Date of Event
- December 4, 2018
- Report Date
- December 6, 2018
- Manufacturer
- MENTOR TEXAS
- Product Code
- FWM
- UDI-DI
- 00081317001256
- PMA / PMN Number
- P990075
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
ON 3/4/19, DEVICE EVALUATION AND INVESTIGATION FINDINGS: UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED NO FLUID. YELLOW MATERIAL WAS OBSERVED WITHIN THE DEVICE AND NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. DURING EVALUATION THE DEVICE LEAK TESTING WAS PERFORMED ACCORDING WITH MENTOR PROCEDURES AND IT REVEALED A RENT WITHIN CREASE AND SHELL ABRASION OBSERVED ON THE POSTERIOR ASPECT, MEASURING APPROXIMATELY <0.1 CM. NO OTHER ANOMALIES WERE OBSERVED. DEFLATION COMPLAINT WAS CONFIRMED. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. MENTOR PRODUCT ANALYSIS LAB CONCLUDED THAT THE RENT OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT WAS CONFIRMED SINCE A RENT WITHIN A CREASE WAS FOUND ON THE DEVICE. THESE FINDINGS ARE CONSISTENT WITH A CREASE/FOLD FAILURE WHICH IS A KNOWN INHERENT RISK ASSOCIATED WITH THE USE OF SALINE-FILLED MAMMARY PROSTHESES AND MAY BE THE RESULT OF ONE OR MORE OF THE FOLLOWING CONTRIBUTING FACTORS: UNDERINFLATION OR OVERINFLATION OF THE DEVICE, CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE - SUCH AS CAPSULAR CONTRACTURE OR TOO SMALL A BREAST POCKET AND FOLDING OR WRINKLING OF THE SHELL IN THE BREAST POCKET. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. THE MANUFACTURING RECORD EVALUATION (MRE) OF LOT NUMBER 5830771 WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE SEVERITY LEVEL FOR THIS COMPLAINT CODE WAS DETERMINED TO BE A S3, WHICH IS DEFINED AS: NECESSITATES INTRUSIVE MEDICAL OR SURGICAL INTERVENTION. AT THIS TIME IS NOT POSSIBLE TO DETERMINE THE ORIGIN OF THE YELLOW MATERIAL OBSERVED. BECAUSE MENTOR PRODUCT ANALYSIS LAB WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON (B)(6) 2019, IT WAS REPORTED TO MENTOR THAT THE DATE OF EXPLANTATION WAS 1/14/19. THE PATIENT EXPERIENCED CAPSULAR CONTRACTURE ON THE RIGHT BREAST IMPLANT. THE PATIENT HAD PTOSIS ON THE LEFT BREAST. THERE WERE NO COMPLICATIONS. THE REPLACEMENT DEVICES WERE SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 350CC, CATALOG NUMBER 3502350, SERIAL NUMBER (B)(4), LOT NUMBER 7630416 ON THE RIGHT BREAST IMPLANT AND WERE SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 350CC , CATALOG NUMBER 3502350, SERIAL NUMBER (B)(4), LOT NUMBER 7630416 ON THE LEFT BREAST IMPLANT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 1/29/2019, IT WAS REPORTED TO MENTOR THAT THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 1/3/19, IT WAS REPORTED TO MENTOR THAT THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 5830771 WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: A SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 325CC, CATALOG NUMBER 3501650, SERIAL NUMBER (B)(4), LOT NUMBER 5857880. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 325CC AND EXPERIENCED SPONTANEOUS DEFLATION ON THE LEFT SIDE. AS A RESULT, THE PATIENT WILL UNDERGO EXPLANTATION ON (B)(6) 2018.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1043884 | MENTOR SMOOTH ROUND MODERATE PROFILE | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | MENTOR TEXAS | 5830771 | 00081317001256 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |