BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC ULTRA PORCINE HEART VALVE

    MDR report key: 2990378 · Received March 5, 2013

    Report

    Report Number
    2025587-2013-00043
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 5, 2013
    Report Date
    March 22, 2013
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL INSPECTION NOTED BROWN DISCOLORATION ON THE TISSUE ADJACENT TO THE LEFT CUSP SHOWING EVIDENCE OF CAUTERIZATION. AREAS OF THE SEWING RING APPEARED TO HAVE BEEN REMOVED DURING EXPLANT EXPOSING THE STENT. ALL LEAFLETS WERE IN THE CLOSED POSITION. ALL LEAFLETS WERE SLIGHTLY STIFF BUT FLEXIBLE EXCEPT WHERE HOST TISSUE EXTENDED ON THE INFLOW. A TINY TEAR OBSERVED THROUGH THE FREE MARGIN OF THE RIGHT CUSP ADJACENT TO THE LEFT RIGHT COMMISSURE APPEARED TO HAVE OCCURRED DURING EXPLANT. THE FREE MARGIN OF THE RIGHT CUSP APPEARED TO SET LOWER THAN THE LEFT CUSP FREE MARGIN, POSSIBLY DUE TO THE ADHERED HOST TISSUE ON THE INFLOW. A SMALL PERFORATION WAS NOTED IN THE LUNULA OF THE LEFT CUSP. THE RIGHT NON-CORONARY AND NON-CORONARY LEFT COMMISSURES APPEARED INTACT. THE LEFT RIGHT COMMISSURE APPEARED TO HAVE BEEN INTACT PRIOR TO THE SMALL TEAR IN THE RIGHT CUSP FREE MARGIN. GLISTENING OFF WHITE PANNUS LINED THE TISSUE AND BASE STITCHING ADJACENT TO ALL CUSPS, ALONG THE INFLOW MARGIN OF ATTACHMENT, INTO ALL INFERIOR COAPTIVE AREAS, AND 1 TO 4.5 MM ONTO ALL CUSPS SIGNIFICANTLY REDUCING THE INFLOW ORIFICE AREA. REMNANTS OF PANNUS REMAINED ATTACHED TO ALL STENT POSTS. AN UNKNOWN AMOUNT OF PANNUS APPEARED TO HAVE BEEN REMOVED ON THE OUTFLOW DURING EXPLANT. RADIOGRAPHY SHOWED NO EVIDENCE OF MINERALIZATION IN THE VALVE AND/OR HOST TISSUE. CONCLUSION: THE DEVICE HISTORY RECORD FOR THE VALVE WAS REVIEWED TO FIND NO ISSUES THAT WOULD HAVE IMPACTED THIS EVENT. BASED ON THE ANALYSIS OF THE DEVICE, REDUCE PERFORMANCE OF THE VALVE IS ATTRIBUTED TO PANNUS. PANNUS LINED THE TISSUE AND BASE STITCHING ADJACENT TO ALL CUSPS, ALONG THE INFLOW MARGIN OF ATTACHMENT, INTO ALL INFERIOR COAPTIVE AREAS, AND 1 TO 4.5 MM ONTO ALL CUSPS SIGNIFICANTLY REDUCING THE INFLOW ORIFICE AREA. A CONCLUSIVE ROOT CAUSE TO THE PANNUS WAS NOT DETERMINED, BUT THIS IS GENERALLY A PATIENT RELATED CONDITION AND A KNOWN FAILURE MODE FOR BIOPROSTHETIC HEART VALVES. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT 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 SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. (B)(6). (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 41 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THE PATIENT PRESENTED WITH AORTIC STENOSIS. THE VALVE WAS EXPLANTED. UPON EXPLANT, A LARGE AMOUNT OF PANNUS WAS FOUND FROM THE NON-CORONARY CUSP TO THE LEFT-CORONARY CUSP. THE PHYSICIAN FEELS THE PANNUS WAS THE CONTRIBUTING FACTOR ON THE PATIENTS HEMODYNAMIC STATUS. THE PATIENT'S PEAK GRADIENT WAS 64.7MMHG,WITH A VALVE EFFECTIVE ORIFICE AREA OF 0.66CM2. THE RESULTING EFFECT WAS CARDIOMEGALY. THE VALVE WAS REPLACED WITH ANOTHER MANUFACTURER'S VALVE. THE VALVE WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT 41 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THE PATIENT PRESENTED WITH AORTIC STENOSIS.THE VALVE WAS EXPLANTED. UPON EXPLANT, A LARGE AMOUNT OF PANNUS WAS FOUND FROM THE NON-CORONARY CUSP TO THE LEFT-CORONARY CUSP. THEPHYSICIAN FEELS THE PANNUS WAS THE CONTRIBUTING FACTOR ON THE PATIENTS HEMODYNAMIC STATUS. THE PATIENTS PEAK GRADIENT WAS 64.7MMHG,WITH A VALVE EFFECTIVE ORIFICE AREA OF 0.66CM2. THE RESULTING EFFECT WAS CARDIOMEGALY. THE VALVE WAS REPLACED WITH ANOTHER MANUFACTURER'S VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94122 MOSAIC ULTRA PORCINE HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA 305U2J21

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR Required Intervention