BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 2851740 · Received November 29, 2012

    Report

    Report Number
    2025587-2012-00185
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    August 1, 2012
    Report Date
    January 4, 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
    MU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: THE PRODUCT HAS BEEN RETURNED AND ANALYSIS IS IN PROGRESS. UPON COMPLETION OF ANALYSIS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THE EXACT IMPLANT DATE AND EXACT DATE OF EXPLANT ARE UNKNOWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL ANALYSIS SHOWED THE VALVE WAS DISCOLORED SHOWING EVIDENCE OF BLOOD CONTACT. ALL LEAFLETS WERE SLIGHTLY STIFF BUT FLEXIBLE POSSIBLY DUE TO BLOOD CONTACT AND/OR THE DECONTAMINATION PROCESS. THE RIGHT AND NON-CORONARY CUSPS WERE INTACT. A SMALL TEAR ON THE TUNICA OF THE NON-CORONARY CUSP ADJACENT TO THE NON-CORONARY LEFT INFERIOR COAPTIVE AREA APPEARED CONSISTENT WITH A PUNCTURE OR LACERATION BY A SHARP INSTRUMENT SUCH AS FORCEPS. THE FREE MARGIN OF THE NON-CORONARY CUSP APPEARED SLIGHTLY MISALIGNED IN RELATION TO THE LEFT AND RIGHT CUSP FREE MARGINS BUT MEASURED WITHIN SPECIFICATIONS. STRIATIONS OR BANDS OF COLLAGEN WERE NOTED ON THE OUTFLOW OF ALL CUSPS. THE LEFT, RIGHT AND NON-CORONARY, LEFT FREE MARGINS APPEARED WAVY AND SLIGHTLY CROWDED WITH THE NON-CORONARY FREE MARGIN APPEARING TO FOLD BACK ON ITSELF. THE HYDRODYNAMIC TESTING DATA SHOWED THE GRADIENTS WERE SLIGHTLY HIGHER AT THE LOW FLOW RATES AND GET VERY CLOSE AT THE 333 ML/SEC TO HISTORICAL DATA. THE REGURGITATIONS WERE VERY CLOSE TO THE BASELINE DATA. HIGH SPEED VIDEO EVALUATION SHOWED THE NON-CORONARY WAS MISALIGNED RELATIVE TO THE RIGHT AND LEFT CUSPS. DURING OPENING, THE NON-CORONARY APPEARED SLIGHTLY STIFFENED AND LAGGED BEHIND THE RIGHT AND LEFT CUSPS, PARTICULARLY AT THE LOWER CARDIAC OUTPUT (~2.5 L/MIN.). THIS MAY BE EXACERBATED BY CONTACT WITH BLOOD AND THE DISINFECTION PROCESS IN-HOUSE. HOWEVER, EVEN AT THE LOWER FLOW RATES, THE LEAFLETS OPENED AND COAPTED FULLY DURING CLOSURE WITHOUT EVIDENCE OF LEAKAGE. CONCLUSION: BASED ON THE ECHOCARDIOGRAM REVIEW OF THE BIOPROSTHETIC VALVE, CAUSE OF LEAFLET IMMOBILITY WAS INCONCLUSIVE. THE STRIATIONS AND BANDS OF COLLAGEN DID NOT APPEAR TO IMPAIR THE FLEXIBILITY OF THE LEAFLETS MAKING THESE ACCEPTABLE PER THE MANUFACTURING PROCEDURE. VISUAL INSPECTION OF THE NON-CORONARY FREE MARGIN APPEARED TO FOLD BACK ON ITSELF, WHICH COULD HAVE CONTRIBUTED TO THE OBSERVED IMMOBILITY OF THIS LEAFLET AT A LOW FLOW EXPERIENCED BY THE CUSTOMER; HOWEVER, DUPLICATION TESTING WAS FOUND ACCEPTABLE EVEN AT A LOW FLOW RATE. MEDTRONIC WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS AND FURTHER INVESTIGATION WILL BE PERFORMED. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(6).

    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 AFTER THE IMPLANT OF THIS BIOPROSTHETIC MITRAL VALVE, WHILE COMING OFF BYPASS, TRANS ESOPHAGEAL ECHOCARDIOGRAM (TEE) NOTED THAT ONE OF THE LEAFLETS WAS NOT MOVING FREELY; GRADIENT ACROSS THE MITRAL VALVE WAS >4MMHG. THE PATIENT WAS PUT BACK ON BYPASS AND CROSS CLAMPED TO LOOK FOR REMNANTS OF THE NATIVE MITRAL SUB VALVULAR APPARATUS. NO STRUCTURE WAS FOUND TO BE INTERFERING WITH THE BIOPROSTHETIC VALVE, BUT IT WAS DECIDED TO REPLACE THE VALVE. THE PHYSICIAN DECIDED TO COMPLETELY REMOVE THE VALVULAR APPARATUS AND IMPLANT A NEW VALVE OF THE SAME MODEL IN A DIFFERENT ORIENTATION. IMMEDIATELY FOLLOWING THE IMPLANT OF THE 2ND MITRAL VALVE WHILE COMING OFF BYPASS, TEE NOTED THAT ONE OF THE LEAFLETS WAS NOT MOVING FREELY. THIS LEAFLET WAS IN THE OPPOSITE POSITION BECAUSE OF THE VALVE'S IMPLANT ORIENTATION. THE GRADIENT ACROSS THE VALVE WAS APPROXIMATELY 2.5MMHG. THE PHYSICIANS ACCEPTED THIS GRADIENT AND THE VALVE REMAINED IMPLANTED. THREE WEEKS POST-OP A MEAN GRADIENT OF >8MMHG WAS NOTED. AN UNKNOWN DURATION AFTER IMPLANT THE PATIENT SUFFERED A STROKE DUE TO MULTIPLE EMBOLISMS SECONDARY TO LOW FLOW. THE SECOND VALVE REMAINED IMPLANTED. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR HYPERTENSION AND ISCHEMIC HEART DISEASE. IT WAS REPORTED THAT THIS WAS THE HOSPITALS SECOND EXPERIENCE IMPLANTING A VALVE OF THIS MODEL IN THE MITRAL POSITION AND THIS PARTICULAR PHYSICIAN'S FIRST EXPERIENCE. THE PHYSICIAN STATED THAT THIS SCENARIO COULD HAVE BEEN RELATED TO A TECHNICAL IMPLANT ISSUE BUT A PRODUCT MALFUNCTION COULD NOT BE EXCLUDED. THE MITRAL VALVE WAS RETURNED FOR ANALYSIS. THIRD PARTY ECHO REVIEW HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY AFTER THE IMPLANT OF THIS BIOPROSTHETIC MITRAL VALVE, WHILE COMING OFF BYPASS, TRANS ESOPHAGEAL ECHOCARDIOGRAM (TEE) NOTED THAT ONE OF THE LEAFLETS WAS NOT MOVING FREELY; GRADIENT ACROSS THE MITRAL VALVE WAS >4 MMHG. THE PATIENT WAS PUT BACK ON BYPASS AND CROSS CLAMPED TO LOOK FOR REMNANTS OF THE NATIVE MITRAL SUB VALVULAR APPARATUS. NO STRUCTURE WAS FOUND TO BE INTERFERING WITH THE BIOPROSTHETIC VALVE, BUT IT WAS DECIDED TO REPLACE THE VALVE. THE PHYSICIAN DECIDED TO COMPLETELY REMOVE THE VALVULAR APPARATUS AND IMPLANT A NEW VALVE OF THE SAME MODEL IN A DIFFERENT ORIENTATION. IMMEDIATELY FOLLOWING THE IMPLANT OF THE 2ND MITRAL VALVE WHILE COMING OFF BYPASS, TEE NOTED THAT ONE OF THE LEAFLETS WAS NOT MOVING FREELY. THIS LEAFLET WAS IN THE OPPOSITE POSITION BECAUSE OF THE VALVE'S IMPLANT ORIENTATION. THE GRADIENT ACROSS THE VALVE WAS APPROXIMATELY 2.5 MMHG. THE PHYSICIANS ACCEPTED THIS GRADIENT AND THE VALVE REMAINED IMPLANTED. THREE WEEKS POST-OP, A MEAN GRADIENT OF >8 MMHG WAS NOTED. AN UNKNOWN DURATION AFTER IMPLANT, THE PATIENT SUFFERED A STROKE DUE TO MULTIPLE EMBOLISMS SECONDARY TO LOW FLOW. THE SECOND VALVE REMAINED IMPLANTED. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR HYPERTENSION AND ISCHEMIC HEART DISEASE. IT WAS REPORTED THAT THIS WAS THE HOSPITAL'S SECOND EXPERIENCE IMPLANTING A VALVE OF THIS MODEL IN THE MITRAL POSITION AND THIS PARTICULAR PHYSICIAN'S FIRST EXPERIENCE. THE PHYSICIAN STATED THAT THIS SCENARIO COULD HAVE BEEN RELATED TO A TECHNICAL IMPLANT ISSUE, BUT A PRODUCT MALFUNCTION COULD NOT BE EXCLUDED. THE MITRAL VALVE WAS RETURNED FOR ANALYSIS. THIRD PARTY ECHO REVIEW HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA T510

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention