BEUDAMED
    FDA Adverse Event Death Summary report: N

    VASCULAR GRAFT

    MDR report key: 2234222 · Received August 17, 2011

    Report

    Report Number
    2242352-2011-01094
    Event Type
    Death
    Date Received
    August 17, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 26, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US., A TECHNICAL EVAL CAN NOT BE PERFORMED. WE WILL, HOWEVER, CONTINUE TO MONITOR AND TREND THIS TYPE OF EVENT TO ENSURE THAT THERE IS NO COMPROMISE TO QUALITY. RESULTS: A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THE PRODUCTION BATCH RECORD FOR THIS PRODUCT SHOWS THAT IT WAS RELEASED IN ACCORDANCE WITH ALL GOVERNING QUALITY ASSURANCE/QUALITY CONTROL PROCEDURES PRIOR TO DISTRIBUTION. THIS REVIEW ALSO EVIDENCED THAT ALL OF THE PIECES THAT WERE RELEASED WITHIN THIS BATCH PASSED INTERNAL SPECIFICATIONS FOR POROSITY. THERE ARE NO SIMILAR OR OTHER COMPLAINTS AGAINST THE BATCH. THE EXACT DATE OF THE DEATH IS UNK AND DOCUMENTED AS (B)(6), 2011 FOR REPORTING PURPOSES. A MEDICAL REVIEW OF THE EVENT AND THE PT'S PRE-EXISTING CONDITION PRIOR TO THIS EVENT EXCLUDES A DIRECT CORRELATION OF THE BLEEDING FROM THE GRAFT AND THE ULTIMATE CAUSE OF DEATH OF THE PT. FOLLOWING OUR INVESTIGATION, OUR CONCLUSION TO THE MOST PROBABLE ROOT CAUSE OF THE EVENT IS OPERATIONAL CONTEXT DUE TO THE PT'S CONDITION PRIOR TO THE EVENT. ITEMS MARKED "NI" ARE UNK TO US AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    (B)(6), THE CVOR/NURSE FROM (B)(6) REPORTED THAT DR. (B)(6) HAD A PT EXPIRED WITHIN 48 HRS AFTER RECEIVING A HEMASHIELD WDV PLATINUM GRAFT IMPLANT. DR. (B)(6) INDICATED THAT THE GRAFT IMPLANT. DR. (B)(6) INDICATED THAT THE GRAFT WAS NOT SEALING AS EXPECTED. THE AMOUNT OF BLOOD LOST WAS NOT QUANTIFIED, BUT WAS NOTED AS SIGNIFICANT AND CONTINUED FOR A LENGTHY PERIOD. DR. (B)(6) DID FINALLY OBTAIN HEMOSTASIS, AND THE GRAFT REMAINED IMPLANTED. WITHIN 48 HRS THERE WAS NO BRAIN FUNCTION PRESENT AND THE PT WAS TAKEN OFF LIFE SUPPORT BY THE FAMILY. ON (B)(6), 2011 THE SALES REP PROVIDED THE PT'S CONDITION PRIOR TO BEING ADMITTED TO THE OPERATING ROOM. HE WAS INITIALLY PLACED ON ECMO AT (B)(6) ON (B)(6), 2011. WITHIN 24 HRS, HE WAS TRANSFERRED TO (B)(6) AND CONTINUED ECMO. THE PT WAS CRITICALLY ILL PRIOR TO THE TRANSFER OF THE CANNULATION SITES IN THE OPERATING ROOM. HE WAS GETTING INOTROPIC/PRESSOR SUPPORT AND VENTILATOR SUPPORT PRIOR TO LOSING HIS DISTAL PULSES. HE ALSO HAD SHOCK LIVER WITH ELEVATED PT, PTT, INR. PT HAD A WITNESSED ARREST AND UNDERWENT MORE THAN AN HR CPR. PT HAD AN INR PRE PROCEDURE OF 4.0 AND WAS CORRECTED TO 2.0 DURING THE PROCEDURE WITH MULTIPLE BLOOD PRODUCTS. HE ORIGINALLY REC'D 5,000 UNITS OF HEPARIN. DUE TO A LOW ACT, AN ADD'L 2,000 UNITS WERE GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCULAR GRAFT DSY MAQUET CARDIOVASCULAR, LLC 175208P 25037297

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death