BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 4132684 · Received October 1, 2014

    Report

    Report Number
    2025587-2014-00718
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    June 2, 2014
    Report Date
    October 2, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, INITIAL VISUAL OBSERVATION INDICATED THAT THE DEVICE SEWING RING WAS EVERTED. THERE APPEARED TO BE TWO VISIBLE AREAS OF POSSIBLE RUPTURES, CONSISTENT FOR A PSEUDOANEURYSM ADJACENT TO LEFT CORONARY SINUS OF VALSALVA. THE REPORTED AREA OF RUPTURE APPEARED TO HAVE BEEN MARKED PURPLE. THE EDGES WERE ROLLED AND SMOOTH, SUGGESTING ¿ADVENTITIAL HEMORRHAGE¿. THE AORTIC WALL ADJACENT TO THE NON-CORONARY CUSP APPEARED TO HAVE BEEN TORN DURING EXPLANT. A SECTION OF AN UNKNOWN CONDUIT REMAINED ATTACHED TO THE OUTFLOW END. BLUE MONOFILAMENT SUTURES REMAINED ATTACHED TO THE OUTFLOW SECTION OF THE VALVE. GREEN AND WHITE MULTIFILAMENT SUTURES REMAINED ATTACHED TO THE SEWING RING. THE RIGHT AND NON-CORONARY CUSPS WERE IN THE CLOSED POSITION. THE RIGHT CUSP WAS PARTIALLY OPEN. ALL LEAFLETS WERE STIFF BUT SLIGHTLY FLEXIBLE. ALL LEAFLETS WERE INTACT. ALL COMMISSURES WERE INTACT. REMNANTS OF GLISTENING OFF-WHITE PANNUS REMAINED ATTACHED TO THE NON-CORONARY AND LEFT CUSPS ALONG THE INFLOW MARGIN OF ATTACHMENT. RADIOGRAPHY SHOWED NO EVIDENCE OF MINERALIZATION IN THE VALVE OR HOST TISSUE. THE DEVICE¿S INSTRUCTIONS FOR USE (IFU) WARNS: ¿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¿ AND ¿CAUTION: DO NOT INVERT THE BIOPROSTHESIS WHEN SUTURING. INVERSION MAY RESULT IN ELONGATED SUTURE HOLES, TEARS, AND/OR DISTORTION LEADING TO STENOSIS AND INCOMPETENCE.¿ 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. RETURNED DEVICE ANALYSIS SHOWED THERE APPEARED TO BE POSSIBLE RUPTURES ADJACENT TO LEFT CORONARY SINUS OF VALSALVA, WHICH IS CONSISTENT FOR A PSEUDOANEURYSM. BASED ON THE RECEIVED INFORMATION AND THE RETURNED PRODUCT ANALYSIS, THE DEFINITIVE CAUSE OF THE PSEUDOANEURYSM COULD NOT BE DETERMINED. HOWEVER, LITERATURE SUGGESTS SEVERAL POSSIBLE CONTRIBUTING CAUSES OF A FREESTYLE RUPTURE (PSEUDOANEURYSM), INCLUDING: STRUCTURAL DEVICE INJURY EITHER FROM THE AGGRESSIVE USE OF FORCEPS DURING IMPLANTATION, THE USE OF BIOGLUE, EMBRYOLOGIC ANATOMIC WEAKNESS, TENSION BY FLUID COLLECTIONS IN THE NONCORONARY SINUS, IMMUNOLOGIC BIOCOMPATIBILITY OF THE VALVE, AND SIZE OF THE VALVE.

    Additional Manufacturer Narrative · 1

    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. THE PRODUCT HAS BEEN RETURNED AND ANALYSIS IS IN PROGRESS. UPON COMPLETION OF ANALYSIS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (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 19 MONTHS POST-IMPLANT A PSEUDOANEURYSM WAS OBSERVED, VIA COMPUTED TOMOGRAPHY (CT) SCAN, ARISING FROM THIS AORTIC ROOT BIOPROSTHESIS. THE DEVICE REMAINED IMPLANTED, WITH MONITORING AND NO ADVERSE PATIENT EFFECTS. IT WAS NOTED THAT THE PATIENT¿S PRE-IMPLANT MEDICAL HISTORY INCLUDED AN ASCENDING AORTIC ARCH ANEURYSM, WHICH ALSO HAD BEEN LEFT AND WAS BEING MONITORED. A SUBSEQUENT CT SCAN SHOWED THE PSEUDOANEURYSM HAD INCREASED IN SIZE. THE DEVICE SUBSEQUENTLY WAS EXPLANTED TWO MONTHS AFTER THE FIRST OBSERVATION OF THE PSEUDOANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610606 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION FR995-29

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention