BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 2940345 · Received February 3, 2013

    Report

    Report Number
    2025587-2013-00016
    Event Type
    Injury
    Date Received
    February 3, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS RECEIVED IN A CLEAR 0.2% GLUTARALDEHYDE SOLUTION, IN THE EXPLANT KIT. THE SEWING RING WAS EXTREMELY EVERTED. LONG GREEN AND WHITE MULTIFILAMENT SUTURE TAILS REMAINED ATTACHED TO THE SEWING RING. THE NON-CORONARY LEFT INFERIOR COAPTIVE AREA APPEARED PROLAPSED POSSIBLY DUE TO THE EVERTED SEWING RING. ALL LEAFLETS WERE SLIGHTLY STIFF BUT FLEXIBLE EXCEPT WHERE THROMBOTIC APPEARING HOST TISSUE EXTENDED ON THE OUTFLOW OF THE NON-CORONARY CUSP. THE NON-CORONARY CUSP APPEARED PARTIALLY CLOSED DUE TO THE ADHERENCE OF HOST TISSUE ON THE LUNULA. ALL COMMISSURES WERE INTACT. TAN TO BROWN THROMBOTIC APPEARING HOST TISSUE PARTIALLY FILLED AND STIFFENED THE BELLY OF THE NON-CORONARY CUSP. THERE WAS NO EVIDENCE OF VEGETATIVE HOST TISSUE IN THE VALVE. RADIOGRAPHY SHOWED NO EVIDENCE OF MINERALIZATION IN THE VALVE AND/OR HOST TISSUE. THE DEVICE HISTORY RECORD, INCLUDING THE STERILIZATION LOT RECORD, WAS REVIEWED AND FOUND TO BE ACCEPTABLE. THE VALVE WAS RETURNED FOR ANALYSIS. THE SEWING RING WAS EXTREMELY EVERTED, WHICH MAY HAVE CONTRIBUTED TO THE NON-CORONARY LEFT INFERIOR COAPTIVE AREA BEING PROLAPSED. THROMBOTIC APPEARING HOST TISSUE PARTIALLY FILLED AND STIFFENED THE BELLY OF THE NON-CORONARY CUSP. THERE WAS NO EVIDENCE OF VEGETATIVE HOST TISSUE OR MINERALIZATION IN THE VALVE AND/OR HOST TISSUE. A REVIEW OF THE OPERATIVE REPORT, WRITTEN FOR THE INITIAL FREESTYLE IMPLANT ON (B)(6) 2012, INDICATES THAT THIS PATIENT HAD SIGNIFICANT HEALTH ISSUES. AN AORTIC RUPTURE WAS DISCOVERED DURING SURGERY, WHICH REQUIRED REPAIR. THE REPORT STATED THAT "THE PATIENT HAS SUB-ACUTE BACTERIAL ENDOCARDITIS WHICH HAS COMPLETELY DESTROYED HIS AORTIC VALVE." THE REPORT ALSO STATED THAT THE SUTURES FOR THE FREESTYLE VALVE HAD TO BE PLACED "DEEP" BECAUSE OF THE ENDOCARDITIS. THE PARAVALVULAR LEAK AND DEHISCENCE MAY BE DUE TO IMPLANT TECHNIQUE POSSIBLY DUE TO THE PATIENT'S HISTORY OF ENDOCARDITIS. THE CAUSE OF THE CONGESTIVE HEART FAILURE APPEARS TO BE DUE TO THE THROMBUS WHICH DEVELOPED ON THE ON THE OUTFLOW OF THE NON-CORONARY CUSP. VALVE THROMBOSIS IS A KNOWN ADVERSE EVENT IN VALVE REPLACEMENT SURGERY AND IS LISTED IN THE IFU. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    THIS BIOPROSTHETIC VALVE HAS BEEN RELEASED FROM HOSPITAL PATHOLOGY AND RETURNED FOR ANALYSIS. ANALYSIS IS PENDING. UPON COMPLETION OF ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(6). (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY TWO WEEKS FOLLOWING THE IMPLANT OF THIS AORTIC ROOT BIOPROSTHETIC VALVE, THERE WAS CONCERN FOR POSSIBLE ENDOCARDITIS. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED TWO PARAVALVULAR LEAKS, MOST PROMINENT BEING UNDER THE ANTERIOR MITRAL VALVE LEAFLET AND JUST OPPOSED ON THE OPPOSITE SIDE OF THE VALVE WAS THE SECOND LEAK. THE VALVE WAS SEEN TO HAVE PARTIAL DEHISCENCE ALONG ITS ATTACHMENT. THE PARAVALVULAR LEAK WAS AT LEAST MODERATE. THERE WAS SIGNIFICANT ABNORMAL TISSUE AND ECHOLUCENCY SEEN WITHIN THE AORTIC ROOT, WHICH MAY REFLECT THE RECENT OPERATIVE STATE. FURTHER IMAGINE WOULD BE INDICATED TO BE CERTAIN THERE WAS NO PERSISTENT ROOT ABSCESS. NO DEFINITIVE VALVULAR MASS OR VEGETATION WAS SEEN ON THE STUDY. TWO DAYS AFTER THE TEE, THE VALVE WAS EXPLANTED. IT WAS NOTED THAT THE PATIENT EXPERIENCED CONGESTIVE HEART FAILURE. IT WAS UNKNOWN IF THIS WAS RELATED TO VALVE FUNCTION. THE VALVE WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY TWO WEEKS FOLLOWING THE IMPLANT OF THIS AORTIC ROOT BIOPROSTHETIC VALVE, THERE WAS CONCERN FOR POSSIBLE ENDOCARDITIS. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED TWO PARAVALVULAR LEAKS, MOST PROMINENT BEING UNDER THE ANTERIOR MITRAL VALVE LEAFLET AND JUST OPPOSED ON THE OPPOSITE SIDE OF THE VALVE WAS THE SECOND LEAK. THE VALVE WAS SEEN TO HAVE PARTIAL DEHISCENCE ALONG ITS ATTACHMENT. THE PARAVALVULAR LEAK WAS AT LEAST MODERATE. THERE WAS SIGNIFICANT ABNORMAL TISSUE AND ECHOLUCENCY SEEN WITHIN THE AORTIC ROOT, WHICH MAY REFLECT THE RECENT OPERATIVE STATE. FURTHER IMAGING WOULD BE INDICATED TO BE CERTAIN THERE WAS NO PERSISTENT ROOT ABSCESS. NO DEFINITIVE VALVULAR MASS OR VEGETATION WAS SEEN ON THE STUDY. TWO DAYS AFTER THE TEE, THE VALVE WAS EXPLANTED. IT WAS NOTED THAT THE PATIENT EXPERIENCED CONGESTIVE HEART FAILURE. IT WAS UNKNOWN IF THIS WAS RELATED TO VALVE FUNCTION. THE VALVE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45736 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA FR995-25

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR Hospitalization| R