CPX4 PLUS SMOOTH TALL HEIGHT 550CC
Report
- Report Number
- 1645337-2022-04046
- Event Type
- Injury
- Date Received
- April 19, 2022
- Date of Event
- March 29, 2022
- Manufacturer
- MENTOR TEXAS
- Product Code
- LCJ
- UDI-DI
- 10081317028441
- PMA / PMN Number
- K182335
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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 MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON MAY 17, 2022, THE MENTOR FAILURE ANALYSIS LAB 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. AS PER DEVICE RECEIVED, , THE FOLLOWING FIELDS HAVE BEEN UPDATED ON THIS FORM: FIELD D1 FOR BRAND NAME HAS BEEN UPDATED TO "CPX4 PLUS SMOOTH TALL HEIGHT 550CC". FIELD D4 FOR CATALOG NUMBER HAS BEEN UPDATED TO "SCPX132TH". FIELD D4 FOR LOT NUMBER HAS BEEN UPDATED TO "9521100". FIELD D4 FOR UNIQUE IDENTIFIER( UDI) HAS BEEN UPDATED TO (B)(4). FIELD G4 FOR PMA/ 510(K) HAS BEEN UPDATED TO "K182335". A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON MAY 26, 2022, DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: MENTOR CONDUCTED A VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE CPX4 PLUS SMOOTH TALL HEIGHT 550CC BREAST TISSUE EXPANDER WAS FOUND TO HAVE A TEAR ON THE POSTERIOR VIEW A MICROSCOPIC EXAMINATION WAS PERFORMED AND THE CAUSE OF THE DEFLATION COULD NOT BE IDENTIFIED. AS THE AUTHORIZATION FORM FOR EXAMINATION WAS NOT RECEIVED THE PRODUCT EVALUATION LAB COULDN´T IDENTIFY A CONCLUSION DUE TO THE SPECIFIC NATURE OF THIS DEFLATION. THE EVALUATION WAS LIMITED TO NON-DESTRUCTIVE TESTING, THEREFORE, THE SHELL THICKNESS WAS NOT MEASURED. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. ALTHOUGH NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: CAUSES OF DEFLATION OF TISSUE EXPANDERS INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING EVENTS: CREASE FOLD FAILURE, INTRAOPERATIVE OR POSTOPERATIVE TRAUMA, EXCESSIVE STRESSES OR MANIPULATIONS AS MAY OCCUR DURING NORMAL, DAILY ROUTINES INCLUDING CUSTOMARY AND PURPOSEFUL TRAUMA SUCH AS THAT WHICH CAN OCCUR DURING VIGOROUS EXERCISE, ATHLETICS, ETC. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH UNKNOWN SIZE UNKNOWN TISSUE EXPANDERS AND EXPERIENCED UNKNOWN SIDE EXPANDER DEFLATION. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2022.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2627783 | CPX4 PLUS SMOOTH TALL HEIGHT 550CC | EXPANDER, SKIN, INFLATABLE | LCJ | MENTOR TEXAS | SCPX132TH | 9521100 | 10081317028441 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |