BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 3875179 · Received June 16, 2014

    Report

    Report Number
    2025587-2014-00391
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 5, 2014
    Report Date
    August 1, 2014
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, THE VALVE WAS IN A VACUUM-PACKED ENVELOPE LACED WITH 10% FORMALIN, FOLDED AND PLACED IN A BUBBLE WRAP ENVELOPE. THE CONTENTS WERE ENCLOSED IN A ZIP LOCK BIOHAZARD BAG. THE VALVE WAS SLIGHTLY DISTORTED WITH THE STENT POSTS APPEARING DEFLECTED. STENT MEASUREMENTS: 23.62 MM X 22.89 MM. STENT POST MEASUREMENTS: LR= 10°, RNC= 5°, NCL= 11°. ALL LEAFLETS WERE SLIGHTLY STIFF BUT FLEXIBLE, EXCEPT WHERE HOST TISSUE EXTENDED ON THE INFLOW AND/OR OUTFLOW. TEARS AND ABRASIONS THROUGH THE LUNULA AND/OR FREE MARGINS OF ALL CUSPS APPEARED CONSISTENT WITH HISTORICAL EVENTS FOR CONTACT WITH THE BIAS CLOTH AND/OR LONG SUTURE TAIL WEAR. TWO SMALL INTRACUSPAL HEMATOMAS WERE OBSERVED ON THE LEFT CUSP. ALL COMMISSURES WERE INTACT. A SMALL, THIN REMNANT OF GLISTENING OFF-WHITE PANNUS REMAINS ATTACHED TO THE TISSUE AND BASE STITCHING ADJACENT TO THE NON-CORONARY CUSP. AN UNKNOWN AMOUNT OF PANNUS APPEARS TO HAVE BEEN REMOVED ON THE INFLOW. RADIOGRAPHY SHOWS NO EVIDENCE OF MINERALIZATION IN THE VALVE AND/OR HOST TISSUE.

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ADDITIONAL REQUESTS HAVE BEEN MADE FOR THE DEVICE¿S RETURN. WITHOUT ITS RETURN, A ROOT CAUSE CANNOT BE DETERMINED. 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. A SUPPLEMENTAL REPORT WILL BE FILED IF THE DEVICE IS RETURNED FOR ANALYSIS OR IF OTHER INFORMATION IS RECEIVED REGARDING THE DEVICE¿S PERFORMANCE OR THE CLINICAL OBSERVATION.

    Additional Manufacturer Narrative · 1

    CONCLUSION: BASED ON THE RECEIVED INFORMATION AND THE RETURNED PRODUCT ANALYSIS, THE REPORTED REGURGITATION IS MOST LIKELY DUE TO THE CUSPAL TEAR AND ABRASION. THE VALVE DISTORTION COULD POTENTIALLY LEAD TO THE LEAFLETS CONTACTING WITH THE BIAS CLOTH THAT COULD CAUSE THE CUSPAL TEAR AND ABRASION. EXACTLY WHEN AND HOW THE DISTORTION OCCURRED CANNOT BE DETERMINED, HOWEVER, PER PROCEDURE EACH MOSAIC VALVE IS INSPECTED FOR DISTORTION AND THIS VALVE PASSED THE INSPECTION PRIOR TO RELEASE FOR DISTRIBUTION. CUSPAL TEAR DUE TO LEAFLET CONTACT WITH BIAS CLOTH IS A KNOWN FAILURE MODE. MEDTRONIC WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR SIMILAR EVENTS SHOULD THEY OCCUR.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE VALVE WOULD BE RETURNED FOR ANALYSIS; TO DATE, THE DEVICE HAS NOT BEEN RETURNED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED, IF THE DEVICE IS RETURNED FOR ANALYSIS, OR WHEN THE INVESTIGATION IS COMPLETED. (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 THIS BIOPROSTHETIC VALVE WAS EXPLANTED 3.5 YEARS AFTER IMPLANT DUE TO MODERATE TO SEVERE REGURGITATION. THE EXPLANT WAS REPORTED BY THE PATIENT¿S SPOUSE, WHO ALSO INDICATED THAT THE EXPLANT PHYSICIAN REPORTED THERE WERE HOLES IN EACH LEAFLET OF THE VALVE. IT WAS REPORTED THAT THE PATIENT WAS SYMPTOMATIC DURING PHYSICAL EXERTION AND STRESS TESTING. ADDITIONAL INFORMATION IS BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352015 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA 305C223

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention