BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 7519357 · Received May 16, 2018

    Report

    Report Number
    3005168196-2018-00997
    Event Type
    Death
    Date Received
    May 16, 2018
    Date of Event
    February 12, 2018
    Report Date
    April 20, 2018
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K160832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE THAT THE REPORT HAS BEEN UPDATED WITH ADDITIONAL INFORMATION RECEIVED ON 15-AUG-2018: THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) ON (B)(6) 2018 AFTER EXPERIENCING A SUBARACHNOID HEMORRHAGE (SAH) WITH A HUNT AND HESS CORE OF IV. DURING THE PROCEDURE THERE WAS A THROMBOEMBOLIC EVENT; THEREFORE, THE PHYSICIAN ADMINISTERED INTEGRILIN. THIS EVENT WAS RESOLVED THE SAME DAY. THE THROMBOEMBOLIC EVENT WAS ADJUDICATED TO BE A NON-SERIOUS DEVICE-RELATED ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE SMART COIL SYSTEM, AND A DEFINITE RELATIONSHIP TO THE PROCEDURE. TWO MONTHS LATER, THE PATIENT PASSED AWAY DUE TO COMPLICATIONS OF THE SAH. THE PHYSICIAN PLACED AN EXTERNAL VENTRICULAR DRAIN (EVD) TO TREAT THE SAH. THE PHYSICIAN BELIEVES THE DEATH WAS DUE TO COMPLICATIONS ARISING FROM THE PROCEDURE AND POTENTIALLY FROM THE TECHNIQUES USED. THE PATIENT'S FAMILY DECIDED TO DISCONTINUE TUBE FEEDS, AND THE PATIENT WAS TRANSFERRED TO THE PROGRESSIVE CARE UNIT (PCU) ON (B)(6) 2018. THE PATIENT PASSED AWAY ON (B)(6) 2018. THE PATIENT'S DEATH WAS ADJUDICATED TO HAVE A PROBABLE RELATIONSHIP TO THE SMART COIL SYSTEM, A DEFINITE RELATIONSHIP TO THE PROCEDURE, AND A PROBABLE RELATIONSHIP TO THE ANEURYSM.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. THROMBOSIS IS A KNOWN AND ANTICIPATED COMPLICATION WITH THESE TYPES OF PROCEDURES AND IS NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED THROMBUS FORMATION WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE DEVICE IS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) ON (B)(6) 2018 AFTER EXPERIENCING A SUBARACHNOID HEMORRHAGE (SAH) WITH A HUNT AND HESS CORE OF IV. DURING THE PROCEDURE THERE WAS A THROMBOEMBOLIC EVENT; THEREFORE, THE PHYSICIAN ADMINISTERED INTEGRILIN. THIS EVENT WAS RESOLVED THE SAME DAY. THE THROMBOEMBOLIC EVENT WAS ADJUDICATED TO BE A NON-SERIOUS DEVICE-RELATED ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE SMART COIL SYSTEM, AND A DEFINITE RELATIONSHIP TO THE PROCEDURE. TWO MONTHS LATER, THE PATIENT PASSED AWAY DUE TO COMPLICATIONS OF THE SAH. THE PHYSICIAN PLACED AN EXTERNAL VENTRICULAR DRAIN (EVD) TO TREAT THE SAH. THE PHYSICIAN BELIEVES THE DEATH WAS DUE TO COMPLICATIONS ARISING FROM THE PROCEDURE AND POTENTIALLY FROM THE TECHNIQUES USED. THE PATIENT'S FAMILY DECIDED TO DISCONTINUE TUBE FEEDS, AND THE PATIENT WAS TRANSFERRED TO THE PROGRESSIVE CARE UNIT (PCU) ON (B)(6) 2018. THE PATIENT PASSED AWAY ON (B)(6) 2018. THE PATIENT'S DEATH WAS ADJUDICATED TO HAVE A PROBABLE RELATIONSHIP TO THE SMART COIL SYSTEM, A DEFINITE RELATIONSHIP TO THE PROCEDURE, AND A PROBABLE RELATIONSHIP TO THE ANEURYSM.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) ON (B)(6) 2018. DURING THE PROCEDURE THERE WAS A THROMBOEMBOLIC EVENT; THEREFORE, THE PHYSICIAN ADMINISTERED INTEGRILIN. THIS EVENT WAS RESOLVED THE SAME DAY. THE THROMBOEMBOLIC EVENT WAS ADJUDICATED TO BE A NON-SERIOUS DEVICE-RELATED ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE SMART COIL SYSTEM, AND A DEFINITE RELATIONSHIP TO THE PROCEDURE. THE PATIENT LATER EXPERIENCED A SUBARACHNOID HEMORRHAGE, AND THE PATIENT'S FAMILY DECIDED TO DISCONTINUE TUBE FEEDS. THE PATIENT WAS TRANSFERRED TO THE PROGRESSIVE CARE UNIT (PCU) ON (B)(6) 2018. THE PATIENT PASSED AWAY ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360828 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| L| R