MENTOR SILTEX ROUND MODERATE PROFILE
Report
- Report Number
- 1645337-2018-07281
- Event Type
- Injury
- Date Received
- December 7, 2018
- Date of Event
- July 18, 2016
- Report Date
- December 6, 2018
- Manufacturer
- MENTOR TEXAS
- Product Code
- FWM
- PMA / PMN Number
- P990075
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
ON 1/28/2019, IT WAS REPORTED TO MENTOR THAT THE MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 5637440, AND NO NON-CONFORMANCES WERE IDENTIFIED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 7/31/2019, DURING EVALUATION OF THE SAMPLE SOME LINES OF SHELL WEAR WERE OBSERVED ON THE ANTERIOR VIEW SUGGESTING IN-VIVO FOLDING OR CREASING OF THE DEVICE. LEAK TESTING REVEALED A TEAR IN THE POSTERIOR VIEW MEASURING APPROXIMATELY LESS THAN 0.1 CM. IN ADDITION ALSO DURING THE LEAK TESTING WAS OBSERVED A LEAKAGE FROM THE VALVE. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RUPTURE REVEALED PARALLEL STRIATIONS. NO ADDITIONAL ANOMALIES WERE OBSERVED. THE ANALYSIS WAS UNABLE TO DETERMINE THE ROOT CAUSE FOR THE LEAKING VALVE. EXCESSIVE MANIPULATION MAY HAVE CAUSED THE VALVE LEAK. THE IFU STATES ¿NOT TO MANIPULATE (I.E., SQUEEZE) THE VALVE EXCESSIVELY, WHICH MAY CAUSE VALVE LEAKAGE¿. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE STRIATIONS ARE CONSISTENT WITH MARKINGS MADE BY A SHARP INSTRUMENT PERFORATING SILICONE MATERIAL. AS STATED IN THE PRODUCT INSERT DATA SHEET, DO NOT ALLOW CAUTERY DEVICES OR SHARP INSTRUMENTS, SUCH AS SCALPELS, SUTURE NEEDLES, HYPODERMIC NEEDLES, HEMOSTATS, ADSON FORCEPS OR SCISSORS TO CONTACT THE DEVICE DURING THE IMPLANTATION OR OTHER SURGICAL PROCEDURES AS THIS CAN RESULT IN RAPTURE. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. BASED ON THE INFORMATION REPORTED AND/OR THE PRODUCT INVESTIGATION, THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH THE MANUFACTURING PROCESS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 12/26/2018, IT WAS REPORTED TO MENTOR THAT THE CATALOG NUMBER FOR THE RIGHT DEVICE WAS SALINE MENTOR SILTEX ROUND MODERATE PROFILE 375CC, CATALOG NUMBER 3542660, SERIAL NUMBER (B)(4), LOT 5637440. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON (B)(6) 2018, 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. (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. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. CONCOMITANT PRODUCTS: A SALINE MENTOR SILTEX ROUND MODERATE PROFILE 375CC , CATALOG NUMBER 3542660, SERIAL NUMBER (B)(4), LOT NUMBER 5932027. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A SALINE MENTOR SILTEX ROUND MODERATE PROFILE 375CC ON THE LEFT BREAST IMPLANT AND WITH SALINE MENTOR BREAST IMPLANT OF UNKNOWN TYPE ON THE RIGHT BREAST IMPLANT AND EXPERIENCED COMPLETE BILATERAL DEFLATION. THE DEFLATION WAS CONFIRMED BY THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE PATIENT HAD UNDERGONE BILATERAL REMOVAL AND REPLACEMENT WITH GEL MENTOR MEMORYGEL BREAST IMPLANT 275CC, CATALOG NUMBER 3507275MC, SERIAL NUMBER (B)(4), LOT NUMBER 6854198 ON THE RIGHT BREAST IMPLANT AND WITH GEL MENTOR MEMORYGEL BREAST IMPLANT 275CC , CATALOG NUMBER 3507275MC, SERIAL NUMBER (B)(4), LOT NUMBER 6873576 ON THE LEFT BREAST IMPLANT ON (B)(6) 2018. THE SURGERY WAS OUTPATIENT. THE PATIENT WAS IN A STABLE AND SATISFACTORY CONDITION AFTER THE SURGERY. THE PATIENT TOLERATED THE PROCEDURE WELL. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 984149 | MENTOR SILTEX ROUND MODERATE PROFILE | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | MENTOR TEXAS | 5637440 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention | SN (B)(4)| SN (B)(4) |