BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET 360 SOFT 7MM X 20CM

    MDR report key: 6149803 · Received December 6, 2016

    Report

    Report Number
    3008881809-2016-00294
    Event Type
    Injury
    Date Received
    December 6, 2016
    Date of Event
    November 11, 2016
    Report Date
    February 27, 2017
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    UDI-DI
    4546540676573
    PMA / PMN Number
    K102672
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, PHYSICAL AS WELL AS A FUNCTIONAL TESTING COULD NOT BE PERFORMED; REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILED TO INDICATE AN ASSIGNABLE CAUSE OR PROBABLE ASSIGNABLE CAUSE FOR THE REPORTED EVENT. BASED ON THE INFORMATION AVAILABLE THE EXACT CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND OF 2 REPORTS. SUBJECT DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF A LEFT INTERNAL CAROTID ARTERY (ICA) UNRUPTURED ANEURYSM, AFTER PLACING THE FIRST SUBJECT COIL UNEVENTFULLY IN THE ANEURYSM, ¿THE PHYSICIAN WAS NOT SURE IF THE COIL WAS HERNIATING INTO THE VESSEL¿. MEDICAL INTERVENTION WITH AN OCCLUSION BALLOON CATHETER WAS PERFORMED IN ORDER TO PUSH BACK THE HERNIATED COIL PART INTO THE ANEURYSM. THE PHYSICIAN INFLATED THE BALLOON FOR 30 SECONDS AND THE DISTAL ICA OR THE ANEURYSM RUPTURED LEADING TO HEMORRHAGE. BLOOD FLOW DISTAL TO THE RUPTURED WAS BLOCKED. THE PATIENT EXPIRED DUE TO BLEEDING. THE PHYSICIAN STATED THAT THE VESSEL RUPTURE WAS RELATED TO THE BALLOON INFLATION AND THE PATIENT DEATH WAS RELATED TO THE BALLOON INFLATION AND THE PATIENT¿S VASCULATURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF A LEFT INTERNAL CAROTID ARTERY (ICA) UNRUPTURED ANEURYSM, AFTER PLACING THE FIRST SUBJECT COIL UNEVENTFULLY IN THE ANEURYSM, ¿THE PHYSICIAN WAS NOT SURE IF THE COIL WAS HERNIATING INTO THE VESSEL¿. MEDICAL INTERVENTION WITH AN OCCLUSION BALLOON CATHETER WAS PERFORMED IN ORDER TO PUSH BACK THE HERNIATED COIL PART INTO THE ANEURYSM. THE PHYSICIAN INFLATED THE BALLOON FOR 30 SECONDS AND THE DISTAL ICA OR THE ANEURYSM RUPTURED LEADING TO HEMORRHAGE. BLOOD FLOW DISTAL TO THE RUPTURED WAS BLOCKED. THE PATIENT EXPIRED DUE TO BLEEDING. THE PHYSICIAN STATED THAT THE VESSEL RUPTURE WAS RELATED TO THE BALLOON INFLATION AND THE PATIENT DEATH WAS RELATED TO THE BALLOON INFLATION AND THE PATIENT¿S VASCULATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798548 TARGET 360 SOFT 7MM X 20CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 19322481 4546540676573

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention