BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 3211685 · Received July 8, 2013

    Report

    Report Number
    2025587-2013-00107
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 31, 2013
    Report Date
    July 29, 2013
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 REVIEW IS PENDING AND A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, A SMALL SECTION OF THE SEWING RING APPEARED EVERTED. DESICCATED TISSUE WAS NOTED ON THE OUTER VALVE WALL ADJACENT TO THE RIGHT CUSP. A 13 MM TEAR NOTED ABOVE THE LEFT CORONARY OSTIA APPEARED TO HAVE OCCURRED DURING IMPLANT. AN 8 X 4 MM HOLE APPEARED TO HAVE BEEN CUT IN THE NON-CORONARY SINUS DURING IMPLANT. THE RIGHT CORONARY BUTTON APPEARED TO HAVE BEEN CUT OFF DURING IMPLANT. ALL LEAFLETS WERE FLEXIBLE AND INTACT. ALL COMMISSURES WERE INTACT. 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. BASED ON THE ANALYSIS, THE TEAR NOTED ABOVE THE LEFT CORONARY OSTIA APPEARED TO HAVE BEEN INDUCED DURING THE IMPLANT PROCEDURE. BASED ON THE INFORMATION PROVIDED AND THE ANALYSIS FINDINGS, IT IS CONCLUDED THAT USE ERROR WAS THE LIKELY CAUSE OF THE EVENT. (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 IMMEDIATELY FOLLOWING THE IMPLANT OF THIS BIOPROSTHETIC VALVE, A TEAR WAS OBSERVED BELOW THE ROOT AT THE OSTIA. THE VALVE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE VALVE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308562 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA 995

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention