BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRANSFORM SUPER COMPLIANT 4MM X 7MM

    MDR report key: 6149801 · Received December 6, 2016

    Report

    Report Number
    3008881809-2016-00293
    Event Type
    Death
    Date Received
    December 6, 2016
    Date of Event
    November 11, 2016
    Report Date
    February 27, 2017
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    MJN
    UDI-DI
    07613327004694
    PMA / PMN Number
    K122576
    Adverse Event
    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. HOWEVER, PATIENT VESSEL PERFORATION, PATIENT DEATH, PATIENT HEMORRHAGE, PATIENT ANEURYSM BURST ARE KNOWN RISK ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND NOTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU). THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WAS ASSIGNED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    THIS IS THE FIRST OF 2 REPORTS. SUBJECT DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING COIL EMBOLIZATION OF A LEFT INTERNAL CAROTID ARTERY (ICA) UNRUPTURED ANEURYSM, AFTER PLACING A FIRST 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 (SUBJECT DEVICE) 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 A FIRST 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 (SUBJECT DEVICE) 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
    798679 TRANSFORM SUPER COMPLIANT 4MM X 7MM CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN STRYKER NEUROVASCULAR CORK 19072511 07613327004694

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| O TARGET COIL (STRYKER)