BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS

    MDR report key: 1776107 · Received July 29, 2010

    Report

    Report Number
    2015691-2010-13802
    Event Type
    Death
    Date Received
    July 29, 2010
    Date of Event
    May 4, 2010
    Report Date
    July 8, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THE PATIENT ALSO HAD ANOTHER DEVICE IMPLANTED, (B) (4). TWO REQUESTS HAVE BEEN MADE TO THE HEALTH-CARE PROVIDER (VIA FAX) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION (ON 07/09/2010 AND 07/16/2010); HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER VIA FAX, ADDITIONAL INFORMATION AND A COPY OF THE OPERATIVE REPORT AND EXPIRATION SUMMARY WERE PROVIDED. IT WAS LEARNED THAT THE PATIENT EXPIRED ON (B)(6)2010 DUE TO SEPSIS. PER THE PATIENT'S EXPIRATION SUMMARY: HOSPITAL COURSE: (PATIENT'S NAME) IS A (B)(6) LADY WITH MULTIPLE PMHX INCLUDING HTN, HLP, PAD, HLP S/P LEFT RENAL ARTERY STENT FOR RAS, COPD, COLON POLYPS, CVA, S/P REPAIR OF BOWL AND BLADDER FISTULA, RESP FAILURE, AND ALSO HAD OPEN HEART SURGERY (AVR WITH CARPENTIER EDWARDS VALVE, MVR WITH SUTURE ANNULOPLASTY AND AORTIC ROOT ENDARTERECTOMY) WITH MULTIPLE POST OP COMPLICATION INCLUDING ISCHEMIC COLITIS WHICH REQUIRED PARTIAL COLECTOMY AND ILEOSTOMY/COLOSTOMY. SHE WAS ORIGINALLY TRANSFERRED TO THE GRACE HOSPITAL FROM THE MAIN CAMPUS AND DEVELOPED PNEUMOTORAX. RENAL CONDITION WAS DETERIORATED AFTER CHEST TUBE INSERTION AND SHE DEVELOPED ACIDOSIS SO, PT WAS TRANSFERRED TO THE UNIT. SHE DEVELOPED SEPSIS AND DID NOT RESPOND WELL TO TREATMENT. FAMILY CHOSE DNR-CC LATER. PT WAS TRANSFERRED TO THE RNF AND RECEIVED COMFORT CARE AND EXPIRED ON (B)(6)2010."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. THE DATE OF PATIENT'S DEATH AND IMPLANT DURATION ARE ALSO UNKNOWN. NO FURTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED. THE DATE OF PATIENT'S DEATH AND IMPLANT DURATION WERE NOT PROVIDED. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2700 R-09K2367

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death