BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 2073467 · Received May 1, 2011

    Report

    Report Number
    2015691-2011-15396
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    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

    ADDITIONAL MANUFACTURER NARRATIVE: EVALUATION SUMMARY ATTACHED: AS RECEIVED, CHARACTERISTIC MARKINGS ON THE VALVE INDICATE A SUTURE WAS LOOPED AROUND COMMISSURE 1. SUTURE TRACK AND PERMANENT INDENTATIONS WERE PRESENT ON THE FREE MARGIN AND CUSP OF LEAFLETS 1 AND 3. THESE INDENTATIONS WERE MOST LIKELY LEFT BY A SUTURE THAT WAS TIED TIGHTLY DOWN AND AGAINST COMMISSURE 1, THUS LEADING TO A GAP AT THE COAPTATION REGION. NO INCONSISTENCIES WERE NOTED IN THE X-RAY, AS THE WIREFORM IS INTACT. THE RETURNED DEVICE WAS EXAMINED VISUALLY AND WITH A LIGHT MICROSCOPE (ASSET # (B)(4)), DIGITAL MICROSCOPE (ASSET# (B)(4)). THE X-RAY USED MET ID# (B)(4). THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. CONCLUSION: SUTURE LOOPS OCCUR WHEN A SUTURE IS CAUGHT ON THE STENT POST OR COMMISSURE AND PREVENTS THE LEAFLETS OF A BIOPROSTHETIC HEART VALVE FROM FUNCTIONING PROPERLY. THIS OCCURS DUE TO IMPROPER TECHNIQUE OR POOR VISUALIZATION OF THE VALVE DURING IMPLANTATION, AND IS NOT A MALFUNCTION OF THE DEVICE. IN MILD CASES, IT MAY GO UNDETECTED AND MAY CAUSE MILD REGURGITATION. IN OTHER CASES, SEVERE REGURGITATION MAY RESULT WHICH MAY BE DETECTED DURING THE PROCEDURE OR AT SOME LATER TIME DURING THE POST-OPERATIVE PERIOD, WHICH MAY REQUIRE REOPERATION. EDWARDS' VALVES HAVE A SPECIALIZED HOLDER DESIGNED TO PREVENT OR MINIMIZE SUTURE LOOPING. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING CAUTION STATEMENT: CAUTION: AVOID LOOPING OR CATCHING A SUTURE AROUND THE OPEN CAGES, FREE STRUTS OR COMMISSURE SUPPORTS OF THE VALVE WHICH WOULD INTERFERE WITH PROPER VALVULAR FUNCTION. THE IFU FURTHER INSTRUCTS THE SURGEON ON HOW TO AVOID SUTURE LOOPING. METHOD: X-RAY.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE SERIAL NUMBER OF THE REPORTED DEVICE WAS NOT REPORTED; THEREFORE, THE DEVICE HISTORY RECORD (DHR) REVIEW CAN NOT BE DONE. THE DEVICE WILL BE RETURNED FOR EVALUATION. ECHO REPORT WAS REQUESTED BUT WAS NOT PROVIDED. PATIENT INFORMATION HAS NOT BEEN DISCLOSED.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE (25MM) WAS EXPLANTED AT IMPLANT DUE TO MITRAL REGURGITATION AS A RESULT OF SUTURE LOOPING. CUSTOMER REPORTED THAT MEDTRONIC'S MOSAIC MITRAL VALVE WAS IMPLANTED FOUR YEARS AGO. MITRAL REGURGITATION (MR) DUE TO TEAR ON THE VALVE WAS OBSERVED AND PERIMOUNT PLUS 6900PJ25 WAS IMPLANTED FOR MITRAL VALVE REPLACEMENT (MVR) TO CORRECT MR ON (B)(6) 2011. AFTER IMPLANT, THE [PATIENT WAS TAKEN OFF] BYPASS AND MR LEVEL III WAS OBSERVED. PERIMOUNT PLUS 6900PJ25 WAS EXPLANTED FOR RE-MVR AND A MECHANICAL VALVE [MAKE AND MODEL UNKNOWN] WAS IMPLANTED AS A REPLACEMENT. CUSTOMER COMMENTED THAT THIS EXPLANT WAS DUE TO THE SUTURE LOOP JAMMING (FAILURE TO USE THE TRICENTRIX HOLDER). NO ADDITIONAL INFORMATION PROVIDED.

    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 11B026

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R