BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPX4 WITH SUTURE TABS MEDIUM HEIGHT SMOOTH EXPANDER

    MDR report key: 11358340 · Received February 22, 2021

    Report

    Report Number
    1645337-2021-01760
    Event Type
    Injury
    Date Received
    February 22, 2021
    Date of Event
    January 1, 2021
    Report Date
    February 3, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    PMA / PMN Number
    K182335
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON MARCH 2, 2021, 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. THE FOLLOWING INFORMATION HAS BEEN UPDATED ON THIS FORM AS PER DEVICE AND PAPERWORK RECEIVED WITH THE DEVICE. - PATIENT'S INITIALS HAVE BEEN UPDATED TO "(B)(6)" UNDER FIELD A1. - FIELD D1 FOR BRAND NAME HAS BEEN UPDATED TO "CPX4 WITH SUTURE TABS MEDIUM HEIGHT SMOOTH EXPANDER". - FIELD D4 FOR CATALOG NUMBER HAS BEEN UPDATED TO "3509213". - FIELD D4 FOR LOT NUMBER HAS BEEN UPDATED TO "9443908". - FIELD D4 FOR UNIQUE IDENTIFIER( UDI) HAS BEEN UPDATED TO "(B)(4)". - FIELDS D6B FOR EXPLANTATION DATE HAVE BEEN UPDATED TO (B)(6) 2021. - 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).

    Additional Manufacturer Narrative · 0

    ON JULY 12, 2021, MENTOR BECAME AWARE THAT THE PREVIOUS REPORT INDICATING DEVICE RETURN INFORMATION WAS REPORTED IN ERROR AS ONLY CONCOMITANT DEVICE WAS RECEIVED. THE DEVICE BELONGS TO MANUFACTURER'S REPORT NUMBER 1645337-2021-01944. A SUPPLEMENTAL REPORT IS BEING SUBMITTED UNDER MANUFACTURER'S REPORT NUMBER 1645337-2021-01944. FIELD H6 FOR TYPE OF INVESTIGATION HAS BEEN UPDATED TO "DEVICE NOT RETURNED" ON THIS FORM. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON MARCH 24, 2021, DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: NO LEAK TEST WAS NECESSARY TO DETERMINE THE LOCATION OF THE TEAR THAT WAS OBSERVED AT THE UNION BETWEEN THE SHELL AND THE SUTURE TAB IN THE 6 O¿CLOCK POSITION. WHEN EVALUATED UNDER A MICROSCOPE THE TEAR PATTERN DID NOT REVEAL PARALLEL STRIATIONS THAT ARE CONSISTENT WITH MARKINGS MADE BY A SHARP INSTRUMENT. THE RESULTS ALSO CONFIRMED THAT THERE WERE NO ABNORMALITIES WITH THE MANUFACTURING OF THE TISSUE EXPANDER THAT WOULD HAVE IMPACTED ITS PERFORMANCE. THEREFORE, WE WERE UNABLE TO IDENTIFY THE ROOT CAUSE OF THIS TEAR. MENTOR ADHERES TO THE HIGHEST STANDARDS OF QUALITY. MENTOR'S QUALITY ASSURANCE PROCESS IS ROBUST FOR EVERY PRODUCT WE MAKE AND REQUIRES THAT EACH MENTOR PRODUCT UNDERGOES A STRINGENT VISUAL INSPECTION AND RIGOROUS TESTING PRIOR TO SHIPMENT. IN ADDITION, MENTOR MAINTAINS A COMPREHENSIVE QUALITY ASSURANCE SYSTEM THAT COMPLIES WITH THE FOOD AND DRUG ADMINISTRATION'S (FDA) GOOD MANUFACTURING PRACTICE REGULATIONS. PRIOR TO SHIPPING, MENTOR'S DEVICES ARE CHECKED TO ENSURE THAT THEY SATISFY THESE STANDARDS IN ACCORDANCE WITH THESE PROCESSES. MENTOR CLOSELY AND CONTINUALLY MONITOR AND REVIEW THE CLINICAL PERFORMANCE AND REAL-WORLD EVIDENCE FOR ALL OF OUR PRODUCTS THROUGH CLINICAL STUDIES, REGISTRIES AND POST-MARKET SURVEILLANCE ACTIVITIES. 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. POTENTIAL CAUSE: WHILE DEFLATION IS HISTORICALLY THE MOST COMMON COMPLICATION RELATED TO TISSUE EXPANDERS, THE RATE OF DEFLATION WITH MENTOR® TISSUE EXPANDERS REMAINS VERY LOW. AN INCIDENT OF THIS NATURE MAY BE THE RESULT OF ONE OR MORE OF THE FOLLOWING FACTORS: OVER-INFLATION OF THE TISSUE EXPANDER, USE OF THE TISSUE EXPANDER IN EMERGING SURGICAL TECHNIQUES NOT IDENTIFIED IN THE INSTRUCTIONS FOR USE (IFU), CONTINUOUS AND SUSTAINED STRESSES TO THE TISSUE EXPANDER, VIGOROUS BODY MOVEMENT (E.G. PHYSICAL EXERCISE) OR EXCESSIVE MANIPULATION/ TRAUMA IN THE REGION OF THE EXPANDER. MENTOR IS COMMITTED TO DELIVERING HIGH-QUALITY TISSUE EXPANDERS AND AN EXCEPTIONAL CUSTOMER EXPERIENCE. 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: UNKNOWN SIDE DEFLATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH AN UNKNOWN SIZE UNKNOWN TISSUE EXPANDER AND WAS PRESENTED WITH UNKNOWN SIDE DEFLATION. AS A RESULT, THE EXPANDER WAS EXPLANTED AT AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256506 CPX4 WITH SUTURE TABS MEDIUM HEIGHT SMOOTH EXPANDER EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS 9443908

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention