BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1712484 · Received June 7, 2010

    Report

    Report Number
    2015691-2010-13520
    Event Type
    Injury
    Date Received
    June 7, 2010
    Date of Event
    May 13, 2010
    Report Date
    May 13, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS BEING RETURNED FOR EVALUATION. CUSTOMER LETTER REQUESTED. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. THIS WAS DETERMINED REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    HEAVY HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE INFLOW OF LEAFLETS 2 AND 3, AND INTO THE ORIFICE AT THE GREATEST DISTANCE OF APPROXIMATELY 8-9MM. AS RECEIVED, THE HOST TISSUE OVERGROWTH HAS SEPARATED FROM THE SURFACE OF LEAFLET 1 AT THE INFLOW ASPECT. HOWEVER, HOST TISSUE OVERGROWTH AT THE INFLOW ASPECT IS SIMILAR TO A CONTINUOUS RING; THIS SUGGESTS THAT LEAFLET 1 WAS MOST LIKELY COVERED BY APPROXIMATELY 8-9MM AS WELL. AT THE OUTFLOW ASPECT, HOST TISSUE OVERGROWTH FUSED THE FREE MARGINS OF LEAFLET 1 AND 3 AT COMMISSURE 1 AT THE OUTFLOW ASPECT BY APPROXIMATELY 6MM. HEAVY DENSE LAYER STRETCHED ACROSS COMMISSURE 1 AND 3 OVER THE FREE MARGIN OF LEAFLET 3, CURLED AND PULLED LEAFLET 3 TO AN OPEN LIKE POSITION. HEAVY HOST TISSUE OVERGROWTH RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO A GAP AT THE COAPTATION REGION. HOST TISSUE OVERGROWTH IS MODERATE TO HEAVY AT THE STENT OUTFLOW. HOST TISSUE OVERGROWTH FUSED HOST ANATOMY TO THE VALVE, EVIDENT AT COMMISSURE 1 AT THE OUTFLOW ASPECT. NO INCONSISTENCIES DETECTED IN THE X-RAY. (MODEL# 6900/P). ADDITIONAL MANUFACTURER NARRATIVE: 06/25/2010 DEVICE WAS RECEIVED FOR DECONTAMINATION AND EVALUATION. 07/14/2010 EVALUATION COMPLETED AND CONCURS WITH CUSTOMER. CORRECTED DATA:. METHOD: X-RAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PERIMOUNT PLUS 6900PJ25 (B) (4) WAS IMPLANTED FOR MVR TO CORRECT MR ON (B) (6) 2007. MC3 4900T26 WAS ALSO IMPLANTED FOR TAP. CUSTOMER COMMENTED THAT THE IMPLANTATION WAS GOOD AND POSTERIOR LEAFLET AND CHORDA TENDINEA WERE CONSERVED. AFTER 2 YEARS OF IMPLANT, PANNUS LIKE TISSUE WAS OBSERVED ON THE POSTERIOR WALL SIDE. PERIMOUNT PLUS 6900PJ25 WAS EXPLANTED FOR RE-MVR DUE TO THE MR ON (B) (6) 2010. ST JUDE M25 WAS IMPLANTED AS A REPLACEMENT."

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY ELEVATED TSH AND PSA RESULTS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. ALL SAMPLES WERE REPEATED AND RECOVERED RESULTS WITHIN THE NORMAL REFERENCE RANGE. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P 07B025

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R