BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 7499572 · Received May 9, 2018

    Report

    Report Number
    3008881809-2018-00216
    Event Type
    Injury
    Date Received
    May 9, 2018
    Date of Event
    February 12, 2018
    Report Date
    June 20, 2018
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED AND/OR COULD BE OBTAINED. THE SUBJECT DEVICE WAS NOT RETURNED; THEREFORE, PHYSICAL AS WELL AS A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. HOWEVER, TRANSIENT NEUROLOGICAL DEFICIT AND TRANSIENT ISCHEMIC ATTACKS (TIA) ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND ARE NOTED AS SUCH IN THE DEVICE DIRECTION FOR USE (DFU). THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS WAS ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 0

    THE NEUROFORM ATLAS STENT WAS USED IN STENT-ASSISTED COIL COILING (SAC) TO EVALUATE THE EFFECTIVENESS AND SAFETY OF NEUROFORM ATLAS SAC FOR INTRACRANIAL ANEURYSMS IN THE FIRST SUCH STUDY. TWENTY-SEVEN CONSECUTIVE PATIENTS, 10 WITH RUPTURED SACCULAR WIDE-NECK ANEURYSMS, WERE TREATED WITH NEUROFORM ATLAS SAC. WE RETROSPECTIVELY ANALYZED DATA FORMAL PATIENTS TREATED WITH THE NEUROFORM ATLAS SAC OF AN INTRACRANIAL ANEURYSM, BOTH RUPTURED AND UNRUPTURED, BETWEEN JUNE 2015 AND DECEMBER 2016. THE MEAN AGE OF THE PATIENTS WAS 55 ± 12.5 YR (RANGE 13-75 YR); 59.3% WERE FEMALE, AND 40.7% WERE MALE. IT WAS REPORTED THAT PATIENT EXPERIENCED TRANSIENT NEUROLOGICAL DEFICIT AT ACA (ANTERIOR CEREBRAL ARTERY) A2 SEGMENT. NO WFNS (WORLD FEDERATION OF NEUROSURGICAL SOCIETIES). THE PATIENT EXPERIENCED MILD DYSMETRIA OF RIGHT ARM RIGHT AFTER PROCEDURE. RESOLVED COMPLETELY WITHIN A DAY. LIKELY A CONTRAST REACTION OR ISCHEMIA.

    Additional Manufacturer Narrative · 1

    THIS IS 11 OF 14 REPORTS. THE SUBJECT DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE NEUROFORM ATLAS STENT WAS USED IN STENT-ASSISTED COIL COILING (SAC) TO EVALUATE THE EFFECTIVENESS AND SAFETY OF NEUROFORM ATLAS SAC FOR INTRACRANIAL ANEURYSMS IN THE FIRST SUCH STUDY. TWENTY-SEVEN CONSECUTIVE PATIENTS, 10 WITH RUPTURED SACCULAR WIDE-NECK ANEURYSMS, WERE TREATED WITH NEUROFORM ATLAS SAC. WE RETROSPECTIVELY ANALYZED DATA FORMAL PATIENTS TREATED WITH THE NEUROFORM ATLAS SAC OF AN INTRACRANIAL ANEURYSM, BOTH RUPTURED AND UNRUPTURED, BETWEEN JUNE 2015 AND DECEMBER 2016. THE MEAN AGE OF THE PATIENTS WAS 55 ± 12.5 YR (RANGE 13-75 YR); 59.3% WERE FEMALE, AND 40.7% WERE MALE. IT WAS REPORTED THAT PATIENT EXPERIENCED TRANSIENT NEUROLOGICAL DEFICIT AT ACA (ANTERIOR CEREBRAL ARTERY) A2 SEGMENT. NO WFNS (WORLD FEDERATION OF NEUROSURGICAL SOCIETIES). THE PATIENT EXPERIENCED MILD DYSMETRIA OF RIGHT ARM RIGHT AFTER PROCEDURE. RESOLVED COMPLETELY WITHIN A DAY. LIKELY A CONTRAST REACTION OR ISCHEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341184 UNKNOWN_NEUROVASCULAR_PRODUCT STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR CORK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other