BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2011259 · Received March 8, 2011

    Report

    Report Number
    2015691-2011-14978
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 7, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: COMPLAINT DATABASE INDICATES NO OTHER REPORTED EVENTS RELATED TO STERILIZATION, ENDOCARDITIS, OR SUSPECTED INFECTION ON ANY DEVICES MANUFACTURED WITHIN THE SAME STERILIZATION LOT OF THE PROVIDED SERIAL NUMBER. EDWARDS LIFESCIENCES MAINTAINS STERILIZATION CONTROLS AND VALIDATION STUDIES WHICH ARE CONDUCTED IN ACCORDANCE WITH ISO STANDARDS AND MEET GLOBAL REGULATIONS ASSURING DEVICE SAFETY. THESE VALIDATION STUDIES DEMONSTRATE HIGH EFFECTIVITY AND RELIABILITY, EXCEEDING STERILIZATION REQUIREMENTS. OVERALL, THE INVESTIGATION REVEALS NOTHING TO INDICATE A QUALITY DEFICIENCY DURING THE MANUFACTURE OF THE DEVICE THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: 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.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE CLINICAL STUDY SITE WROTE "SUBJECT 2109 HAS ENDOCARDITIS AND WILL BE HAVING THE VALVE REMOVED THIS WEEK." ON (B)(6) 2011 THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 4 MONTHS. THE OPERATIVE REPORT LISTS "PROSTHETIC AORTIC VALVE ENDOCARDITIS WITH SEVERE PARAVALVULAR AORTIC INSUFFICIENCY AND PRESUMED INFECTION OF PERMANENT BIVENTRICULAR PACEMAKER" AS THE POST-OPERATIVE DIAGNOSIS. ADDITIONAL INFORMATION: SUBJECT HAD PROGRESSIVE SHORTNESS OF BREATH, ORTHOPNEA, PND AND INCREASED ABDOMINAL AND LEG SWELLING SINCE LATE (B)(6) 2010. ECHO PERFORMED ON (B)(6) SHOWED MOD TO SEVERE AORTIC REGURGITATION, SEVERE TRICUSPID REGURGITATION AND MODERATE MITRAL REGURGITATION. TEE SHOWED WIDE OPEN SEVERE AORTIC INSUFFICIENCY LIKELY PARAVALVULAR LEAK AND SEVERE MITRAL REGURGITATION. EXPLANTED DUE TO PERIVALVULAR LEAK, ENDOCARDITIS ORGANISM: STAPH. EPIDERMIDIS. DEVICE HAD NO THROMBUS, VEGETATION, SUTURE INTERFERENCE, CALCIFICATION OR FIBROSIS. HOWEVER THE DEVICE DID SHOW DEHISCENCE AND THERE WAS AORTIC ROOT ABSCESS." PER OPERATIVE REPORT: THE PATIENT IS A (B)(6) YEAR OLD MAN SEVERAL MONTHS STATUS POST MINIMALLY INVASIVE AORTIC VALVE REPLACEMENT. THE PATIENT HAD BEEN DOING WELL FOLLOWING DISCHARGE FOR A FEW MONTHS BUT THEN BEGAN TO DEVELOP SYMPTOMS OF HEART FAILURE. DIAGNOSTIC EVALUATION SHOWED SEVERE PARAVALVULAR AORTIC INSUFFICIENCY. HE WAS ADMITTED TO THE HOSPITAL, AND BACTERIAL ENDOCARDITIS WAS DIAGNOSED WITH STAPH SPECIES GROWN FROM ALL CULTURES. THE PATIENT WAS STARTED ON ANTIBIOTICS AND TREATED FOR HEART FAILURE. HE WAS ULTIMATELY STABILIZED AND WAS REFERRED FOR SURGERY. BECAUSE OF THE ENDOCARDITIS AND RECENT PACEMAKER SYSTEM, EXPLANTATION OF HIS PERMANENT PACEMAKER WAS REQUESTED. THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS. UPON INSPECTION OF THE PROSTHETIC AORTIC VALVE, IT APPEARED TO BE DEHISCED ALONG THE NON-CORONARY AREA AND THE LEFT CORONARY AREA. MINIMAL TRACTION WAS PLACED ON THE VALVE, AND THE REMAINING SUTURES WERE CUT. THE VALVE WAS DELIVERED, AND CULTURES WERE OBTAINED FROM THE AORTIC ROOT. EXTENSIVE AND AGGRESSIVE DEBRIDEMENT OF THE AORTIC ROOT WAS NOW CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX R-10E1289

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R