BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 1953316 · Received January 7, 2011

    Report

    Report Number
    2015691-2011-14637
    Event Type
    Death
    Date Received
    January 7, 2011
    Date of Event
    September 23, 2010
    Report Date
    December 8, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT ALSO HAD ANOTHER RELATED EVENT; PLEASE REFERENCE THE OTHER MEDWATCH SUBMITTED UNDER PATIENT IDENTIFIER (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): PANNUS. DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE DEVICE WAS NOT PROVIDED TO EDWARDS FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. LATE PROSTHETIC VALVE ENDOCARDITIS, OCCURRING MORE THAN 60 DAYS AFTER SURGERY, IS USUALLY CAUSED BY AN INFECTION WHICH OCCURS ELSEWHERE IN THE BODY, AND THEN SEEDS THE VALVE. THE MOST FREQUENT CAUSES ARE DENTAL PROCEDURES, UROLOGICAL INFECTIONS AND INTERVENTIONS, AND INDWELLING CATHETERS. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY. HOST TISSUE/PANNUS GROWTH IS A COMPLEX PROCESS TRIGGERED BY THE INTERACTION BETWEEN THE HOST AND THE DEVICE AND IS HIGHLY VARIABLE AMONG PATIENTS. LITERATURE DEFINES PANNUS AS A TYPE OF SCARRING AND TISSUE INGROWTH. IT IS NOT CURRENTLY POSSIBLE TO PREDICT THE OCCURRENCE AND SEVERITY FOR ANY GIVEN PATIENT WITH A BIOPROSTHETIC HEART VALVE/ANNULOPLASTY RING. A CERTAIN DEGREE OF HOST TISSUE GROWTH IS EXPECTED. HOWEVER, ABNORMAL OR SEVERE PANNUS GROWTH CAN EVENTUALLY AFFECT THE FUNCTION OF THE VALVE. ACCORDING TO LITERATURE, PANNUS TYPICALLY OCCURS BETWEEN 12 MONTHS TO 5 YEARS. PANNUS OCCURRING PRIOR TO 12 MONTHS IS RARE AND SUGGESTS PATIENT FACTORS MAY HAVE PLAYED A SIGNIFICANT ROLE. SINCE THE MECHANISM OF HOST TISSUE GROWTH IN BIOPROSTHETIC HEART VALVES/ANNULOPLASTY RINGS IS STILL NOT FULLY UNDERSTOOD, THE ROOT CAUSE FOR THE HOST TISSUE GROWTH FOR THIS PARTICULAR VALVE CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 3 YEARS AND 1 MONTH. THIS PATIENT WAS ADMITTED WITH PROSTHETIC VALVE ENDOCARDITIS AND UNDERWENT AVR. IT WAS ALSO LEARNED THAT THIS PATIENT EXPIRED 3 DAYS LATER FROM SEPTIC SHOCK. ACCORDING TO THE PATIENT'S DISCHARGE SUMMARY, THIS IS THE PATIENT'S SECOND BOUT OF ENDOCARDITIS AS THE PATIENT HAD ENDOCARDITIS BACK IN 2007. HE RECEIVED AN ECHO, WHICH DEMONSTRATED THICKENING OF THE LEAFLETS ONLY. THE PATIENT WAS SEEN ALSO SEEN BY ANOTHER DOCTOR FOR A SECOND OPINION, WHO CONFIRMED THE FINDINGS AND RECOMMENDED HIGH RISK REOPERATIVE AORTIC VALVE SURGERY. THIS WAS PERFORMED ON (B)(6) 2010 AND THE PATIENT HAD SEVERE INVOLVEMENT WITH INFECTED PANNUS THROUGHOUT AND AN ABSCESS IN THE ANNULAR RING ALL OF WHICH WAS DEBRIDED AND MANAGED AND THE SECOND VALVE (EDWARDS VALVE) REPLACED. THE PATIENT DID WELL INTRAOPERATIVELY, HAD SOME PROBLEMS WITH HIS SVR REQUIRING VASOPRESSIN AND LEVOPHED TO MAINTAIN THE BLOOD PRESSURE. HE WAS SEVERELY AND PROFOUNDLY ACIDOTIC OVERNIGHT AND ALSO HAD A HIGH CARDIAC OUTPUT. HE SLOWLY IMPROVED BUT DID GO INTO RENAL FAILURE AND DID REQUIRE CRRT. BY (B)(6) 2010, HE REMAINED INTUBATED. CHEST X-RAY WORSENING AND WHAT APPEARED TO BE INFLAMMATORY FLUFFY INFILTRATES BILATERALLY. BY (B)(6) 2010, THE PATIENT HAD DETERIORATED, WORSENING SATURATIONS, HYPOTENSION, INCREASING REQUIREMENTS FOR INOTROPES. IT WAS APPARENT THE PATIENT HAD OVERWHELMING SEPSIS AND MULTIORGAN FAILURE, NO EVIDENCE OF BLEEDING. THE OUTLOOK WAS POOR AND THIS WAS CONVEYED TO THE FAMILY. NO SIGNIFICANT IMPROVEMENT BY (B)(6) 2010, NO BLEEDING, WORSENING CHEST X-RAY, WORSENING O2 SATURATIONS. HE WAS MADE A NO CODE STATUS AND HE WAS PRONOUNCED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX R-07C0479

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death| R