BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH

    MDR report key: 9578798 · Received January 10, 2020

    Report

    Report Number
    1645337-2020-00668
    Event Type
    Injury
    Date Received
    January 10, 2020
    Date of Event
    December 1, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    PMA / PMN Number
    K182335
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE DEVICE IS A MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH, 275CC TISSUE EXPANDER, CATALOG #3509211, LOT #7691985, UDI #(B)(4) 510(K) #K182335. 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. ON (B)(6) 2020, MENTOR RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT IDENTIFIER IS P.B. ON (B)(6) 2020, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, IT WAS REPORTED A DEFLATION ON A TISSUE EXPANDER. DURING VISUAL EVALUATION OF THE SAMPLE, A TEAR WAS OBSERVED ON THE POSTERIOR ASPECT MEASURING APPROXIMATELY 2.5 CM. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RUPTURE REVEALED PARALLEL STRIATIONS CONSISTENT WITH A RUPTURE WITH A SHARP OBJECT. 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 RUPTURE. 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. COMPLAINT INFORMATION WILL BE INCLUDED IN COMPLAINT TRENDING THAT IS REVIEWED AND MONITOR BY QUALITY ASSURANCE ON A REGULAR BASIS TO DETERMINE IF FURTHER ACTION IS NECESSARY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 01/27/2020, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: THE PATIENT DOB IS (B)(6) 1958. THE EVENT DATE IS (B)(6) 2019. THE PATIENT AGE AT THE TIME OF EVENT IS 61 YEARS OLD. THE PATIENT SEX IS FEMALE. THE PATIENT RACE IS WHITE, AND HER ETHNICITY IS NOT HISPANIC/LATINO. THE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH THE SUSPECT MEDICAL DEVICE. IT WAS THE LEFT BREAST TISSUE EXPANDER THAT DEFLATED. THE IMPLANTATION DATE IS (B)(6) 2019. AFTER EXPLANTATION, THE SUSPECT MEDICAL DEVICE WAS REPLACED WITH AN UNSPECIFIED GEL BREAST PROSTHESIS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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: TISSUE EXPANDER DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN BREAST SURGERY WITH AN UNSPECIFIED MENTOR TISSUE EXPANDER DEVICE THAT DEFLATED AFTER IMPLANTATION. IT WAS REPORTED THAT THE TISSUE EXPANDER IS LEAKING. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37211 MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS 7691985

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention