BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 1874352 · Received October 19, 2010

    Report

    Report Number
    2015691-2010-14223
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    July 27, 2010
    Report Date
    September 29, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. CUSTOMER LETTER NOT REQUESTED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: NO PATIENT HISTORY HAS BEEN PROVIDED. OPERATIVE REPORT WAS REQUESTED BUT NOT RECEIVED. THE SURGEON RESPONDED THAT THE DEVICE IS UNAVAILABLE FOR RETURN. THE EVENT WAS REPORTED AS A VALVE EXPLANT AT IMPLANT WITH NO ADDITIONAL INFORMATION. THIS EVENT IS TYPICALLY A RESULT OF INAPPROPRIATE SIZING, DISTORTION OF THE VALVE DURING IMPLANTATION AND/OR THE PATIENT'S ANATOMY, AND NOT A MALFUNCTION OF THE DEVICE. HOWEVER, NO CONCLUSION CAN BE MADE AT THIS TIME AS TO THE ROOT CAUSE FOR THE EXPLANT OF THIS DEVICE. SINCE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS TO WHETHER THE PATIENT HAD OR HAD NOT BEEN TAKEN OFF BYPASS, IT HAS BEEN DETERMINED THAT THE EXPLANT OF THE EDWARDS DEVICE WAS CONSIDERED A REPORTABLE EVENT. THE HOSPITAL DID PROVIDE THE FOLLOWING INFORMATION REGARDING ADDITIONAL DEVICES USED FOR THIS PATIENT. AFTER EXPLANT OF THE EDWARDS LIFESCIENCES DEVICE, A HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR VASCULAR GRAFT, LOT# 12879393, AND A MITROFLOW AORTIC PERICARDIAL HEART VALVE, S/N (B)(4), WERE IMPLANTED ON THE (B)(6) 2010. THE POSITIONS OF THESE TWO DEVICES WERE NOT NOTED. A HAND-WRITTEN NOTE ACCOMPANIES THIS INFORMATION "DIED 30/7/2010". THE SURGEON'S RESPONSE GAVE NO INDICATION THAT THE PATIENT HAD EXPIRED. THEREFORE, NO CAUSE OF DEATH WAS PROVIDED. THERE IS NO INFORMATION THAT SUGGESTS THAT THESE DEVICES WERE EXPLANTED PRIOR TO OR AFTER THE PATIENT'S DEATH AS NO OPERATIVE REPORT, DISCHARGE SUMMARY OR AUTOPSY WERE PROVIDED.

    Description of Event or Problem · 1

    AN EVENT WAS RECEIVED THROUGH THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY. THIS "REGISTRY" IS A PATIENT TRACKING MECHANISM FOR SERIALIZED DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET REGISTRY. PATIENT AND DEVICE STATUS ARE REPORTED THROUGH THE REGISTRY. THIS INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED BY EDWARDS AS A CONVENTIONAL CUSTOMER COMPLAINT. IN THIS CASE, A RESPONSE WAS RECEIVED FROM THE SURGEON CONFIRMING THAT THE DEVICE WAS EXPLANTED, HOWEVER NO REASON WAS GIVEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF ZERO DAYS, DUE TO UNKNOWN REASONS. NO FURTHER DETAILS WERE PROVIDED. INFORMATION LEARNED FROM OUR IMPLANT PATIENT REGISTRY. THERE HAS BEEN NO RESPONSE TO OUR REPEATED ATTEMPTS ON 09/30/2010 AND 10/07/2010 TO CONTACT THE HEALTH CARE PROVIDER REGARDING THE DETAILS OF THE EVENT AND PRODUCT RETURN.

    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 S-10E1271

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R