BEUDAMED
    FDA Adverse Event Death Summary report: N

    TARGET 360 SOFT COILS

    MDR report key: 3833656 · Received May 21, 2014

    Report

    Report Number
    MW5036209
    Event Type
    Death
    Date Received
    May 21, 2014
    Date of Event
    January 31, 2013
    Report Date
    May 13, 2014
    Manufacturer
    STRYKER
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT WAS ENROLLED ON THE (B)(4) TRIAL, A MULTI-CENTER PROSPECTIVE ANEURYSM CLINICAL TRIAL, AND WAS RANDOMIZED TO THE BARE PLATINUM TREATMENT ARM. THE PT IS A (B)(6) MALE WHO PRESENTED WITH A UNRUPTURED ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY. THE ANEURYSM WAS COILED ON (B)(6) 2012. THE PT WAS DOING WELL AT THEIR (B)(6) DAY VISIT. THE PATIENT THEN MOVED TO (B)(6) WITH HIS DAUGHTER. THE SITE CALLED SEVERAL PHONE NUMBERS TO REACH THE PATIENT FOR A FOLLOW UP VISIT AND SPOKE TO A FRIEND WHO REPORTED THE PT DIED LAST YEAR DUE TO AN AORTA RUPTURE. THE FRIEND DID NOT HAVE ANY FURTHER INFO. THE SITE HAS BEEN UNSUCCESSFUL CONTACTING THE FAMILY. HOWEVER, THE SITE WAS ABLE TO RECEIVE MEDICAL RECORDS FROM THE HOSPITAL IN WHICH THE PATIENT EXPIRED. THE PATIENT WITH A HISTORY OF AAA SURGICAL REPAIR HAD A CARDIAC ARREST WITH PULSE LESS ELECTRICAL ACTIVITY. HE HAD COLLAPSED ON THE FLOOR AND EXPIRED A SHORT TIME LATER DESPITE RESTORATIVE EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301359 TARGET 360 SOFT COILS COILS HCG STRYKER 14874317
    301360 TARGET 360 SOFT COILS COILS HCG STRYKER 15449037
    301361 TARGET 360 SOFT COILS COILS HCG STRYKER 15520547

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death