BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 3524136 · Received December 17, 2013

    Report

    Report Number
    2025587-2013-00205
    Event Type
    Injury
    Date Received
    December 17, 2013
    Date of Event
    November 21, 2013
    Report Date
    April 2, 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
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, THE VALVE WAS DISCOLORED, SHOWING EVIDENCE OF BLOOD CONTACT, WITH A PLEDGET AND A PORTION OF A SUTURE OBSERVED IN THE SEWING RING. THE LEAFLETS WERE IN A SEMI-RELAXED POSITION, WHICH IS A NORMAL FINDING FOR THIS VALVE AS IT IS PROCESSED WITH THE LEAFLETS IN RELAXED STATE. ALL LEAFLETS WERE SLIGHTLY STIFF BUT FLEXIBLE, WHICH IS EXPECTED DUE TO BLOOD CONTACT AND THE DECONTAMINATION PROCESS (WHICH INCLUDES A HIGH CONCENTRATE OF A TISSUE FIXATION COMPONENT), BOTH OF WHICH ARE KNOWN TO CAUSE STIFFNESS OF THE TISSUE. ALL LEAFLETS WERE INTACT. HYDRODYNAMIC PULSE DUPLICATION TESTING WITH HIGH-SPEED VIDEO OBSERVATION SHOWED THAT THE LEFT-RIGHT COMMISSURE POST AND THE RIGHT/NON-CORONARY POST APPEARED BENT INWARD. WHEN THE LEAFLETS COAPTED DURING TESTING, THE RIGHT CUSP FREE MARGIN SHIFTED AND DROPPED BELOW THE LEFT CUSP FREE MARGIN BETWEEN THE POINT OF COAPTATION AND THE COMMISSURE; HOWEVER, THERE WAS NO LOSS OF COAPTATION OBSERVED, AS THE LEAFLETS FULLY CLOSED WITH NO VISIBLE EVIDENCE OF GAPPING OR LEAKAGE. THE VIDEO REVIEW SHOWED NO OTHER ANOMALIES. FLOW THROUGH THE VALVE WAS DOCUMENTED USING ECHOCARDIOGRAPHY, DIGITAL HIGH-SPEED IMAGING AND FLOW METER ASSESSMENT. CONCLUSION: BASED ON THE GROSS ANALYSIS AND IN-VITRO TESTING RESULTS, NO ANOMALIES WERE NOTED WITH REGARD TO VALVE COAPTATION, AND A CONCLUSIVE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED: UPDATE TO THE EVENT DESCRIPTION: MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 25MM BIOPROSTHETIC VALVE (25A10F7558), THE PHYSICIAN HAD THE VALVE SUTURED IN PLACE, THE PHYSICIAN NOTED THAT THE VALVE WOULD NOT COAPT PROPERLY. THIS FAILURE WAS MACROSCOPIC EVIDENT TO THE HUMAN EYE. THE VALVE WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A 23MM BIOPROSTHETIC VALVE (B030661). THE 23MM VALVE WAS NOT SUTURED INTO PLACE BECAUSE THE PHYSICIAN SEEN THE SAME COAPT FAILURE PRIOR TO SUTURING. SUBSEQUENTLY THAT VALVE WAS NOT USED AND REPLACED WITH ANOTHER 25MM VALVE WITH SUCCESS. THE TOTAL PUMP TIME WAS NOTED TO BE 5 HOURS. IT WAS NOTED NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. REQUESTS HAVE BEEN MADE TO RETURN THE VALVES FOR ANALYSIS. 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 PICTURE OF THE VALVE PROVIDED BY THE CUSTOMER SHOWED BLOOD CONTACT ON THE SEWING RING INDICATING THAT IMPLANT HAD BEEN ATTEMPTED. AN ADDITIONAL PICTURE WAS PROVIDED OF THE VALVE IN THE IMPLANT POSITION. AT THIS TIME, A CONCLUSIVE CAUSE OF THE VALVE NOT COAPTING COULD NOT BE DETERMINED. IF THE PRODUCTS ARE RETURNED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(6).

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED. CONCLUSION: THE DEVICE HISTORY RECORD REVIEW IS IN PROCESS ONCE THE REVIEW IS COMPLETE A FOLLOW-UP REPORT WILL SUBMITTED. THE RETURN OF THE DEVICE HAS BEEN REQUESTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE INCLUDED IN THE SUPPLEMENTAL REPORT. (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 DURING THE IMPLANT OF THIS 25MM BIOPROSTHETIC VALVE (B)(4), THE PHYSICIAN HAD THE VALVE SUTURED IN PLACE, DURING THE INTRAOPERATIVE ECHOCARDIOGRAM, THE PHYSICIAN NOTED THAT THE VALVE WOULD NOT COAPT PROPERLY. THE VALVE WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A 23MM BIOPROSTHETIC VALVE (B)(4). AGAIN THE VALVE WAS SUTURED INTO PLACE AND DURING THE INTRAOPERATIVE ECHOCARDIOGRAM THE PHYSICIAN NOTED THE VALVE WOULD NOT COAPT PROPERLY. SUBSEQUENTLY THAT VALVE WAS REMOVED AND REPLACED WITH ANOTHER 25MM VALVE WITH SUCCESS. THE TOTAL PUMP TIME WAS NOTED TO BE 5 HOURS. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. THE VALVES ARE EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658312 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA 305U225 25A10F7558

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention