MENTOR TISSUE EXPANDER
Report
- Report Number
- 1645337-2019-08283
- Event Type
- Injury
- Date Received
- February 4, 2019
- Date of Event
- July 25, 2018
- Report Date
- January 13, 2019
- Manufacturer
- MENTOR TEXAS
- Product Code
- LCJ
- UDI-DI
- 00081317002413
- PMA / PMN Number
- K842883
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JO
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
UPON REVIEW OF THIS FILE, MENTOR DETERMINED THAT ADDITIONAL CLARIFICATION COULD BE PROVIDED REGARDING THE OFF-LABEL USAGE DOCUMENTED IN THIS REPORT. IN ADDITION TO BEING IMPLANTED LONGER THAN SIX MONTHS, THIS DEVICE IS ALSO NOT INDICATED FOR USE IN BREAST-RELATED TISSUE EXPANSION PROCEDURES. MANUFACTURER'S REFERENCE NUMBER: (B)(4) ADDITIONAL INFORMATION ABOUT THE NATURE OF THE OFF-LABEL USAGE PROVIDED IN H10.
AFTER ADDITIONAL REVIEW OF THIS EVENT BY MENTOR'S CLINICAL SAFETY AND REGULATORY TEAMS ON 22-JUL-2022, IT HAS DETERMINED THAT THE DEVICE WAS NOT USED OFF-LABEL. AS A RESULT, MEDICAL DEVICE PROBLEM CODE OFF-LABEL USE NO LONGER APPLIES. THE DEVICE WAS IMPLANTED LONGER THAN SIX MONTHS, WHICH IS NOT IN ACCORDANCE WITH OUR INSTRUCTIONS FOR USE. THEREFORE H6 MEDICAL DEVICE PROBLEM CODE A23/USE OF DEVICE PROBLEM HAS BEEN ADDED. MANUFACTURER'S REFERENCE NUMBER: (B)(4). H6 MEDICAL DEVICE PROBLEM CODE OFF-LABEL USE WAS REPLACED WITH A23/USE OF DEVICE PROBLEM.
ON 2/13/2019, 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. LAST EFFECTIVE FILL WAS ON (B)(6) 2018 AND AFTER THAT THE EXPANDER WAS BEING FILLED WITHOUT EXPANSION. EXPANDER WAS RUPTURED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
AFTER CLINICAL, SECONDARY REVIEW OF THIS FILE PERFORMED ON 10/5/2020, IT WAS DECIDED TO ADD CODE OFF-LABEL USE TO MORE ACCURATELY CAPTURE THE REPORTED EVENT . SINCE THE A MENTOR TISSUE EXPANDER 400CC WAS IMPLANTED FOR LONGER THAN 6 MONTHS: THE DATE OF IMPLANT (B)(6) 2018, DATE OF EXPLANT IS (B)(6) 2019, THIS TISSUE EXPANDER WAS USED OFF-LABEL PER MENTOR IFU. IN ADDITION, PMA CODE WAS ERRONEOUSLY OMITTED. THE ACTUAL CODE IS K842883. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON (B)(6) 2020, DURING THE VISUAL EVALUATION, AN ANOMALY WAS OBSERVED ON THE ANTERIOR VIEW OF THE DEVICE CONSISTENT WITH A CREASE/FOLD. A TEAR WAS ALSO OBSERVED AT THE JUNCTION BETWEEN THE SHELL AND THE PATCH, ON THE POSTERIOR VIEW. MICROSCOPIC EXAMINATION WAS PERFORMED AND THE CAUSE OF THE RUPTURE COULD NOT BE IDENTIFIED. PER MENTOR INSTRUCTIONS FOR USE (IFU), TISSUE EXPANDERS ARE INTENDED FOR TEMPORARY SUBCUTANEOUS OR SUBMUSCULAR IMPLANTATION AND ARE NOT INTENDED FOR USE BEYOND SIX MONTHS. THEREFORE, THIS DEVICE WAS USED IN AN OFF LABEL MANNER. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS LOT. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. COMPLAINT INFORMATION IS CONSISTENTLY ANALYZED AND MONITORED BY MENTOR QUALITY ASSURANCE TO DETERMINE WHEN FURTHER ACTION IS NECESSARY. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON (B)(6) 2019, IT WAS REPORTED TO MENTOR THAT THE DEVICE EVALUATION AND INVESTIGATION HAVE BEEN COMPLETED. UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED NO FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. DURING THE INITIAL EVALUATION A CREASE WAS OBSERVED ON THE ANTERIOR ASPECT AND A RENT AT JUNCTURE PATCH WAS ALSO OBSERVED. MICROSCOPIC EXAMINATION WAS PERFORMED. NO EVIDENCE OF INSTRUMENT DAMAGE WAS OBSERVED. 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 RUPTURE WAS FOUND ON THE DEVICE. NONETHELESS, A MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT WAS PERFORMED AND IT DID NOT PROVIDE CONCLUSIVE EVIDENCE OF WHAT COULD BE THE ROOT CAUSE. THE SEVERITY LEVEL FOR THIS COMPLAINT CODE WAS DETERMINED TO BE A S3, WHICH IS DEFINED AS: NECESSITATES INTRUSIVE MEDICAL OR SURGICAL INTERVENTION. 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).
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. THE MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN AUGMENTATION REVISION PROCEDURE WITH A MENTOR TISSUE EXPANDER 400CC AND EXPERIENCED RUPTURE ON THE LEFT IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH GEL MENTOR MEMORYGEL BREAST IMPLANT 325CC, CATALOG NUMBER 3503254BC, LOT NUMBER 7565926 ON (B)(6) 2019.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 95275 | MENTOR TISSUE EXPANDER | EXPANDER, SKIN, INFLATABLE | LCJ | MENTOR TEXAS | 3504305M | 7516448 | 00081317002413 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Female | Required Intervention |