BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THV 1000-21 3F AORTIC BIO 21MM

    MDR report key: 3002176 · Received March 13, 2013

    Report

    Report Number
    2031780-2013-00001
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MEDTRONIC ATS 3F THERAPEUTICS
    Product Code
    LWR
    PMA / PMN Number
    P060025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, PIECES OF THE SEWING RING, TWO COMPONENTS OF THE VALVE AND HOST TISSUE WERE RECEIVED WITH THE VALVE FOR ANALYSIS. PART OF THE SEWING RING APPEARED TO HAVE BEEN REMOVED DURING EXPLANT. ALL LEAFLETS WERE SLIGHTLY STIFF BUT FLEXIBLE POSSIBLY DUE TO BLOOD CONTACT AND/OR THE DECONTAMINATION PROCESS; BOTH ARE KNOWN TO CAUSE STIFFNESS OF THE TISSUE. THE TUNICA OF ALL LEAFLETS APPEARED INTACT. ALL COMMISSURES APPEARED TO HAVE BEEN REMOVED DURING EXPLANT. TWO COMMISSURES WERE RECEIVED WITH THE VALVE. REMNANTS OF GLISTENING OFF-WHITE PANNUS REMAINED ATTACHED TO THE EXISTING INFLOW MARGIN OF ATTACHMENTS OF ALL CUSPS, INTO TWO INFERIOR COAPTIVE AREAS AND 1 TO 2.5 MM ONTO ALL CUSPS WHICH SHOWED EVIDENCE OF A REDUCED INFLOW ORIFICE AREA. PANNUS REMAINED ATTACHED TO THE INFLOW AND OUTFLOW ASPECT ON THE SECTION OF SEWING RING REMOVED DURING EXPLANT. A REMNANT OF PANNUS APPEARED TO COVER THE TOP OF ONE COMMISSURE. A REMNANT OF PANNUS WAS RECEIVED WITH THE VALVE. RADIOGRAPHY SHOWED NO EVIDENCE OF MINERALIZATION IN THE VALVE AND/OR HOST TISSUE. CONCLUSION: DUE TO THE RETURNED CONDITION OF THE VALVE, ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE PARAVALVULAR LEAK WAS LIKELY DUE TO THE REPORTED SUTURE FRACTURE AT THE ANNULUS. IN ADDITION, ANALYSIS REVEALED HOST TISSUE OVERGROWTH WAS PRESENT, LIKELY REDUCING THE PERFORMANCE OF THE VALVE. THIS FINDING IS GENERALLY CONSIDERED A PATIENT RELATED CONDITION. 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. (B)(6). (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT 15 MONTHS FOLLOWING THE IMPLANT OF THIS BIOPROSTHETIC VALVE, TRANSESOPHAGEAL ECHOCARDIOGRAPHY REVEALED A PARAVALVULAR LEAK. SUBSEQUENTLY, THE VALVE WAS EXPLANTED. UPON EXPLANT, A SUTURE FRACTURE AT THE ANNULUS WAS OBSERVED. ANOTHER TISSUE VALVE WAS IMPLANTED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104955 THV 1000-21 3F AORTIC BIO 21MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC ATS 3F THERAPEUTICS 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention