BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 9844760 · Received March 17, 2020

    Report

    Report Number
    2015691-2020-10998
    Event Type
    Injury
    Date Received
    March 17, 2020
    Date of Event
    February 11, 2020
    Report Date
    February 21, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: A4, B5, B7, F10. H10: ADDITIONAL MANUFACTURER NARRATIVE: PROSTHETIC ENDOCARDITIS WITH OR WITHOUT VEGETATION, OF VALVES AND ANNULOPLASTY RINGS IS A SERIOUS COMPLICATION OF VALVE REPLACEMENT AND VALVE REPAIR SURGERIES DESPITE IMPROVEMENTS IN PROSTHESES TYPES, SURGICAL TECHNIQUES, AND INFECTION CONTROL MEASURES. THIS INFECTION IS GENERALLY CATEGORIZED INTO EARLY (ONSET USUALLY LESS THAN 60 DAYS POSTOPERATIVE) AND LATE (ONSET GREATER THAN 60 DAYS POST-IMPLANTATION). LATE PROSTHETIC ENDOCARDITIS RESEMBLES NATIVE VALVE ENDOCARDITIS IN TERMS OF ETIOLOGICAL MICROBES, AND SOURCES OF CONTAMINATION ARE PRESUMABLY SIMILAR. LATE ENDOCARDITIS OCCURS DUE TO THE IMPLANT BEING SEEDED FROM AN INFECTION OR MICROBIAL CONTAMINATION FROM ELSEWHERE IN THE BODY. DENTAL, GENITOURINARY, AND GASTROINTESTINAL MANIPULATION ARE KNOWN CAUSES OF TRANSIENT BACTEREMIA, WHICH CAN PLACE A PATIENT AT RISK FOR PROSTHETIC ENDOCARDITIS. ADDITIONAL PROCEDURES PLACING PATIENTS AT RISK FOR PROSTHETIC ENDOCARDITIS INCLUDE URETHRAL CATHETERIZATION, COLONOSCOPY, BARIUM ENEMAS, AND SURGICAL PROCEDURES. LATE PROSTHETIC ENDOCARDITIS IS NOT IN ANY WAY RELATED TO THE STERILIZATION OR PACKAGING PROCESS OF THE DEVICE. THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED WITH THE AVAILABLE INFORMATION; HOWEVER, THE ENDOCARDITIS IN THIS CASE WAS MOST LIKELY IMPACTED BY THE PATIENT'S COMORBIDITIES AND HISTORY OF IV DRUG ABUSE. PER DOC-0103625 REV F, THE SUBJECT DEVICE WAS NOT REQUESTED TO BE RETURNED FOR EVALUATION AS THE PATIENT WAS POSITIVE FOR ENDOCARDITIS. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. THERE WERE NO ISSUES IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 33MM 7300TFX (IPR-1199262-20200224-1) PERICARDIAL VALVE IN THE TRICUSPID POSITION DEVELOPED RECURRENT ENDOCARDITIS AFTER AN IMPLANT DURATION OF APPROXIMATELY 8 MONTHS. DUE TO ACTIVE IV DRUG ABUSE, THE PATIENT WAS TREATED WITH ANGIOVAC EVACUATION OF ENDOCARDITIS LESIONS ACROSS THE TV AND IV ANTIBIOTICS. NINE MONTHS LATER, AFTER COMPLETING A REHAB PROGRAM SHE UNDERWENT A REDO TVR FOR TRICUSPID STENOSIS AND REGURGITATION SECONDARY TO ENDOCARDITIS. THE EXPLANTED VALVE WAS REPLACED WITH A 33MM 7300TFX VALVE (IPR-1199262-20200224-2). BECAUSE OF THE PATIENT¿S ANATOMY, THE VALVE ENTERED AT AN ACUTE ANGLE AND WAS NOT PROPERLY SEATED. ONE OF THE VALVE SUTURES CAPTURED ONE OF THE VALVE POSTS, THE VALVE WAS THEN EXPLANTED AND REPLACED WITH ANOTHER 33MM 7300TFX VALVE. THIS VALVE SEATED WELL WITHOUT INSUFFICIENCY OR SIGNIFICANT GRADIENT. THE PATIENT WAS TRANSPORTED TO THE ICU IN STABLE CONDITION HAVING TOLERATED THE PROCEDURE QUITE NICELY. ON POD #3, THE PATIENT DEVELOPED ATRIAL FLUTTER, REQUIRED CARDIOVERSION, AND CONVERTED TO NSR. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION ON POD #4.

    Additional Manufacturer Narrative · 1

    BIOPROSTHETIC TISSUE VALVES CAN DETERIORATE WITH TIME AND EVENTUALLY FAIL CONTRIBUTING TO REGURGITATION AND/OR STENOSIS. STRUCTURAL VALVE DETERIORATION (SVD) IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANTS AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. ALTERNATIVELY, NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR REGURGITATION AND/OR STENOSIS. IN THIS CASE, MINIMAL INFORMATION REGARDING THIS VALVE REPLACEMENT PROCEDURE WAS RECEIVED AND ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CONDITION OF THE DEVICE, PATIENT'S MEDICAL HISTORY, OR POSSIBLE COMORBIDITIES HAVE BEEN MADE. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. HOWEVER, THIS EVENT WAS MOST LIKELY IMPACTED BY THE PROGRESSION OF THE PATIENT¿S UNDERLYING VALVULAR DISEASE PATHOLOGY WITH OR WITHOUT STRUCTURAL VALVE DETERIORATION AND/OR NONSTRUCTURAL DYSFUNCTION. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN PERFORMED. THE HEALTHCARE PROVIDER HAS NEITHER RETURNED THE EXPLANTED VALVE NOR PROVIDED ANY ADDITIONAL INFORMATION AT THIS TIME. THE DEVICE WAS NOT REQUESTED FOR RETURN AS THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 33MM 7300TFX (IPR-1199262-20200224-1)PERICARDIAL VALVE IN THE TRICUSPID POSITION UNDERWENT A VALVE REPLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF ONE (1) YEAR, SIX (6) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 33MM 7300TFX VALVE (IPR-1199262-20200224-2). THIS VALVE WAS EXPLANTED AT IMPLANT DUE TO UNKNOWN REASONS AND REPLACED WITH ANOTHER 33MM 7300TFX PERICARDIAL VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308727 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX33

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R