BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 2831994 · Received November 14, 2012

    Report

    Report Number
    2025587-2012-00178
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 18, 2012
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, THE SEWING RING WAS EVERTED. NOTE: PER THE IFU, SECTION 10.2 "BIOPROSTHESIS IMPLANTATION- TAKE CARE NOT TO EVERT (ROLL OUTWARD) THE INFLOW END OF THE BIOPROSTHESIS WHEN SUTURING THE VALVE TO THE PATIENT'S ANNULUS. EVERSION COULD DAMAGE THE VALVE TISSUE." THERE IS ONE VISIBLE AREA OF A POSSIBLE PSEUDOANEURYSM ADJACENT TO THE RIGHT CORONARY. THE EDGES WERE ROLLED AND SMOOTH SUGGESTING "ADVENTITIAL HEMORRHAGE." A TISSUE SECTION IN THE NON-CORONARY SINUS AREA WAS THIN AND STRETCHED BUT NOT RUPTURED SUGGESTING A POSSIBLE PSEUDOANEURYSM. NOTE: THE OTHER TWO AREAS IN QUESTION COULD NOT BE IDENTIFIED. ALL LEAFLETS WERE SLIGHTLY STIFF BUT FLEXIBLE EXCEPT WHERE HOST TISSUE EXTENDED ON THE INFLOW AND OUTFLOW. ALL LEAFLETS WERE INTACT. ALL COMMISSURES WERE INTACT. THIN REMNANTS OF PANNUS EXTENDED 1 TO 3 MM ALONG THE TUNICA OF ALL CUSPS WITH A LARGE REMNANT OBSERVED IN THE LEFT RIGHT INFERIOR COAPTIVE AREA. PANNUS LINED THE INTIMAL SURFACE OF THE LEFT CORONARY SINUS WALL AND ANASTOMOSIS. PINK TO MAROON COLORED THROMBOTIC HOST TISSUE LINED THE BELLY OF THE RIGHT AND NON-CORONARY CUSPS. AN UNKNOWN AMOUNT OF HOST TISSUE APPEARED TO HAVE BEEN REMOVED ON THE INFLOW. RADIOGRAPHY SHOWED NO EVIDENCE OF MINERALIZATION IN THE VALVE AND/OR HOST TISSUE. 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. REDUCED PERFORMANCE OF THE VALVE IS ATTRIBUTED TO HOST TISSUE OVERGROWTH. THESE FINDINGS ARE GENERALLY CONSIDERED A PATIENT RELATED CONDITION. ADDITIONALLY, ANALYSIS FINDINGS INDICATE THAT IMPROPER IMPLANT TECHNIQUE MAY HAVE CONTRIBUTED TO THE CLINICAL OBSERVATION. (B)(6). (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT 22 MONTHS FOLLOWING THE IMPLANT OF THIS 29 MM AORTIC ROOT BIOPROSTHETIC VALVE (AORTIC ROOT REPLACEMENT WITH CONCOMITANT ASCENDING ARCH REPAIR), CT SCAN NOTED A SMALL PSEUDOANEURYSM AT THE PROXIMAL ANASTOMOSIS SITE. ALSO NOTED WERE 2 PSEUDOANEURYSMS ARISING FROM THE ANTERIOR, POSTERIOR ASPECTS OF THE ASCENDING AORTIC GRAFT WHICH SHOWED AN INCREASE IN SIZE FROM THE LAST SCAN 4 MONTHS PRIOR. THE PATIENT REMAINED ASYMPTOMATIC. DUE TO THE INCREASING SIZE OF THE PSEUDOANEURYSMS, SURGICAL INTERVENTION WAS PERFORMED (AORTIC ROOT RECONSTRUCTION WITH REPLACEMENT OF THE ASCENDING AORTA AND HEMIARCH WITH HOMOGRAFT). THE VALVE WAS EXPLANTED WITH NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA FR995-29

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention