BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 3062035 · Received April 16, 2013

    Report

    Report Number
    2025587-2013-00057
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 6, 2013
    Report Date
    April 16, 2013
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. REVIEW OF THE STERILITY LOT RECORD SHOWED THAT THE BIOLOGICAL INDICATORS RESULTED NEGATIVE FOR THE TISSUE AND SOLUTION. THE PYROGEN TEST PASSED. THERE WERE NO OTHER COMPLAINTS REPORTED FOR INFECTION/ENDOCARDITIS UNDER THIS STERILITY LOT. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: ALTHOUGH REQUESTED FROM THE USER FACILITY, THE PRODUCT HAS NOT BEEN RETURNED; THEREFORE, EVALUATION OF THE DEVICE WAS UNABLE TO BE PERFORMED. MEDTRONIC HAS COMPLETED A THOROUGH REVIEW OF THE DEVICE HISTORY RECORD (DHR). BASED ON THE DHR REVIEW OF THIS DEVICE, THERE ARE NO NON-CONFORMANCES IDENTIFIED REGARDING THE MANUFACTURING PROCESS OR STERILIZATION PROCESS. THIS INCLUDES A REVIEW OF RAW MATERIALS (INCLUDING HARVESTED TISSUE), MANUFACTURING PROCESS STEPS (INCLUDING TIME DURATION), PACKAGING AND LABELING, AND OVERALL STERILIZATION LOAD. ALL DEVICES UNDER THIS STERILIZATION LOT WERE MANUFACTURED PER APPROVED AND RELEASED MANUFACTURING PROCESSES AND THE DEVICES MET ALL APPLICABLE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION. REVIEW OF THE STERILITY LOT RECORD CONFIRMS THAT THE BIOLOGICAL INDICATORS (BI) TEST NEGATIVE FOR BOTH TISSUE AND SOLUTION. THE PYROGEN TEST SHOWS ACCEPTABLE TEST RESULTS. ADDITIONALLY, THERE WERE NO OTHER COMPLAINTS REPORTED FOR INFECTION AND/OR ENDOCARDITIS UNDER THIS STERILITY LOT, AND THERE HAVE BEEN NO OTHER HANCOCK II VALVES REPORTED FOR ENDOCARDITIS IN WHICH MYCOBACTERIUM CHELONAE WAS IDENTIFIED. ADDITIONAL INFORMATION RECEIVED FROM THE USER FACILITY INDICATES THE ORGANISM WAS NOT CULTURED, RATHER WAS IDENTIFIED THROUGH POLYMERASE CHAIN REACTION (PCR) TESTING. THERE HAVE BEEN NO SIMILAR CASES YIELDING MYCOBACTERIUM CHELONAE NOTED AT THE USER FACILITY. THE PATIENT DID NOT HAVE A HISTORY OF INFECTIONS AND WAS NOT PRESCRIBED ANTIBIOTICS PRIOR TO THE INITIAL SURGICAL IMPLANT PROCEDURE, AND DID NOT HAVE SYMPTOMS OF INFECTION UPON PRESENTING TO THE FACILITY. CONCLUSION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE HAVE BEEN MULTIPLE ATTEMPTS OF COMMUNICATION WITH THE INSTITUTION TO REQUEST ADDITIONAL INFORMATION. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE FOR THE INFECTION 9 MONTHS POST OPERATIVE CANNOT BE DETERMINE AT THIS TIME. MEDTRONIC WILL CONTINUE TO PARTNER WITH THE USER FACILITY TO OBTAIN THE REQUESTED INFORMATION TO DETERMINE ROOT CAUSE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, OR IF UPON COMPLETION OF THE INVESTIGATION, FURTHER DETAILS OR CONCLUSIONS ARE MADE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT INVESTIGATION: MEDTRONIC IS IN THE PROCESS OF INVESTIGATING THIS EVENT, INCLUDING AN ATTEMPT TO RETRIEVE THE EXPLANTED DEVICE. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT 7 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED DUE TO POSITIVE RESULTS OF MYCOBACTERIUM CHELONAE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161990 HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA T510C

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention