BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS

    MDR report key: 1668304 · Received April 27, 2010

    Report

    Report Number
    2015691-2010-13224
    Event Type
    Injury
    Date Received
    April 27, 2010
    Date of Event
    March 4, 2010
    Report Date
    April 7, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. ON 07/22/2010, NO INCONSISTENCIES DETECTED VISUALLY OR IN THE X-RAY. ON 7/22/10, VALVE SENT TO (B)(4) FOR FUNCTIONAL TESTING. ON 09/24/2010 RESEARCH AND DEVELOPMENT COMPLETED THE FUNCTIONAL TEST AND CONCLUDED WITH THE FOLLOWING: "THIS VALVE WAS EXPLANTED AT IMPLANT DUE TO "AN ECCENTRIC CENTRAL JET". NO ECHOCARDIOGRAPHY RECORDING WAS PROVIDED, THUS THE 'ECCENTRIC CENTRAL JET" AND BEHAVIOR OF THE VALVE OBSERVED IN VIVO CANNOT BE CONFIRMED. EDWARDS STANDARDIZED IN VITRO TESTING SHOWS MODERATE NON-CENTRAL LEAKAGE THOUGH THE SEWING RING AND STENT ASSEMBLY AREAS OF THE VALVE AS-RECEIVED. THIS IS TYPICAL FOR THIS TYPE OF BIOPROSTHESIS AND SHOULD REDUCE TO A NEGLIGIBLE LEVEL SHORTLY AFTER THE EFFECT OF HEPARIN IS REVERSED DURING THE INITIAL OPERATION. IT IS POSSIBLE THAT THE IN VIVO REGURGITATION REPORTED IS THIS TYPICAL INITIAL LEAKAGE THROUGH THE STENT ASSEMBLY. REDUCTION OF THE INITIAL LEAKAGE WAS CONFIRMED BY SUBSEQUENT TESTING OF THE VALVE AFTER SEALING. THE SEALED TOTAL REGURGITANT FRACTION IS MORE THAN 14 TIMES LOWER THAN THE 10% MAXIMUM ALLOWED PER ISO(B)(4) FOR THIS SIZE VALVE. THESE RESULTS INDICATE THAT THE LEAKAGE REPORTED IN VIVO WAS PROBABLY THROUGH THE STENT, AND WOULD PROBABLY HAVE RESOLVED AFTER THE REVERSAL OF HEPARIN. NEVERTHELESS, DUE TO THE EXPOSURE OF THE VALVE TO BLOOD AND FORMALIN, THE RESULTS FROM IN VITRO TESTS MAY BE DIFFERENT FROM THE OBSERVED BEHAVIOR OF THE VALVE IN VIVO."

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. REQUESTED A COPY OF THE TEE CD AND THE OPERATIVE REPORT TO INCLUDE PATIENT CONDITIONS AND MEDICATIONS ON 04/22/2010. REQUESTED RETURN OF THE DEVICE FOR EVALUATION. THE DHR REVIEW HAS BEEN STARTED. CUSTOMER LETTER WAS NOT REQUESTED.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT SHE JUST RECEIVED A FREESTYLE FREEDOM LITE METER. CUSTOMER REPORTED THERE WAS A READING IN METER'S MEMORY THAT WAS NOT HERS. CUSTOMER ALSO REPORTED BECAUSE OF THE METER ISSUE, SHE EXPERIENCED SYMPTOMS OF HYPERGLYCEMIA. CUSTOMER FURTHER REPORTED VISITING HER DOCTOR WHO DIAGNOSED CUSTOMER WITH SEVERE HYPERGLYCEMIA AND STARTED CUSTOMER ON A NEW ORAL DIABETES MEDICATION. NO EMERGENT THIRD-PARTY MEDICAL INTERVENTION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    ON (B) (6), THE SURGEON MENTIONED TO AN EMPLOYEE OF EDWARDS LIFESCIENCES THAT AN INTRA-OPERATIONAL EXPLANT (I.E. "EXPLANT-AT-IMPLANT") OF THE SUBJECT DEVICE HAD OCCURRED DURING AN AORTIC VALVE REPLACEMENT PROCEDURE OF (B) (6). THE EXPLANT OF THE MODEL 3300TFX (21MM) AORTIC VALVE WAS PERFORMED FOLLOWING THE OBSERVATION OF AN ECCENTRIC CENTRAL JET BEFORE THE PATIENT WAS TAKEN OFF BYPASS. THE SUBJECT VALVE WAS REPLACED WITH A MODEL 3300TFX (19MM) THAT PERFORMED AS INTENDED. THE PATIENT'S SURGICAL RECOVERY WAS UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX 09L310

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R