BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3002998 · Received March 13, 2013

    Report

    Report Number
    2015691-2013-19541
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. PARTIAL OR TOTAL OCCLUSION OF THE CORONARY OSTIA IS A RECOGNIZED COMPLICATION OF AN AORTIC VALVE REPLACEMENT. IT IS TYPICALLY THE RESULT OF A TECHNICAL ERROR DURING VALVE IMPLANT AND NOT RELATED TO A PRODUCT MALFUNCTION. IN THIS CASE, THE SURGEON CORRECTED THE ISSUE WITH CABG AND THERE HAS BEEN NO REPORT OF DEVICE MALFUNCTION AFTER CABG. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT REMAINS IMPLANTED. THE PATIENT'S CONDITION WAS REPORTED AS "STABLE". NO UPDATE HAS BEEN PROVIDED ON THE CURRENT PATIENT CONDITION. ECHO WAS REQUESTED BUT IS NOT AVAILABLE. WITHOUT ADDITIONAL INFORMATION, WE ARE UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    REPORTEDLY, RIGHT CORONARY OCCLUSION WAS OBSERVED IN A PATIENT WHO HAD A 19MM VALVE IMPLANTED. THE CUSTOMER REPORTED THAT A 19MM VALVE WAS IMPLANTED FOR AORTIC VALVE REPLACEMENT (AVR) TO CORRECT AORTIC STENOSIS (AS) ON (B)(6) 2013. ON (B)(6) 2013, THE PATIENT DESCRIBED SYMPTOMS OF CHEST DISCOMFORT AND NECK PAIN. THE SYSTOLIC BLOOD PRESSURE WAS 50 MMHG. BRADYCARDIA WAS DEVELOPED AS PULSE RATE WAS 48. ELECTROCARDIOGRAM FINDINGS WERE ELEVATED, ST-SEGMENT AND HYPERACUTE T WAVE IN LEADS II, III AND AVF. WAVEFORM OF ATRIOVENTRICULAR BLOCK WAS OBSERVED IN ELECTROCARDIOGRAM MONITOR. AT CATHETER TEST, 99% STENOSIS WAS OBSERVED AT AN OPENING AREA OF RIGHT CORONARY ARTERY. IN CORONARY ANGIOGRAPHY, THERE WAS A TIME WHEN RIGHT CORONARY ARTERY WAS NOT IMAGED DUE TO OCCLUSION, AND A TIME WHEN RIGHT CORONARY ARTERY WAS IMAGED SINCE OCCLUSION WAS RELIEVED. IN ANGIOGRAPHY OF ASCENDING AORTA, THERE WAS NOT A PROBLEM WITH THE DEVICE OBSERVED. THE CUSTOMER ATTEMPTED PERCUTANEOUS CORONARY INTERVENTION FOR RIGHT CORONARY ARTERY. HOWEVER, THE OPENING AREA OF RIGHT CORONARY ARTERY WAS SO CLOSE TO THE SEWING RING THAT INSERTING A GUIDE WIRE WAS TOO DIFFICULT. CORONARY ARTERY BYPASS GRAFTING (CABG) WAS PERFORMED ON (B)(6) 2013. AFTER CABG WAS PERFORMED, THE PATIENT CONDITION WAS STABLE AND UNDER TREATMENT AS OF (B)(6) 2013. THE DEVICE WILL NOT BE RETURNED SINCE IT REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106106 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX 12F172

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R