BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS PERICARDIAL PATCH

    MDR report key: 1780029 · Received August 2, 2010

    Report

    Report Number
    2015691-2010-13827
    Event Type
    Death
    Date Received
    August 2, 2010
    Date of Event
    May 4, 2010
    Report Date
    July 8, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXZ
    PMA / PMN Number
    K082139
    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, PLEASE REFERENCE THE OTHER MEDWATCH REPORT FILED UNDER PATIENT IDENTIFIER #(B)(4). TWO REQUESTS WERE 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 RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED, AND THERE WERE NO NONCONFORMANCE FOUND RELATED TO THIS EVENT.

    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 05/04/2010 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 PATIENTS' DEATH AND IMPLANT DURATION ARE ALSO UNKNOWN. NO FURTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    THE HOSPITAL CONTACTED THE BAXTER SALES REPRESENTATIVE AND REPORTED THAT 4 UNITS OF LOT NUMBER 09I03S PRESENTED BROKEN FIBERS. THERE WAS NO PATIENT INJURY. THE FACILITY WAS CONTACTED AND INDICATED THAT 2 OUT OF THE 4 SAMPLES WERE REUSED. THE NUMBER OF REUSES IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS PERICARDIAL PATCH PERICARDIAL PATCH DXZ EDWARDS LIFESCIENCES 4700 R-09K2492

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death