BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 14379596 · Received May 12, 2022

    Report

    Report Number
    3012931345-2022-00095
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    July 20, 2021
    Report Date
    August 10, 2022
    Manufacturer
    STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
    Product Code
    NRY
    PMA / PMN Number
    K132641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE DHR COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER REMAINS UNKNOWN, THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. NO VISUAL OR FUNCTIONAL INSPECTION WAS PERFORMED DUE TO SUBJECT RETRIEVER DEVICE WAS NOT RETURNED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. IT WAS REPORTED IN A LITERATURE ARTICLE THAT DURING THE CRANIOCERVICAL MECHANICAL THROMBECTOMY PROCEDURE, THE PATIENT EXPERIENCED A DISSECTION OF THE CERVICAL VERTEBRAL ARTERY (V2 SEGMENT). HEPARIN AND ASPIRIN WAS ADMINISTERED TO THE PATIENT AS ADDITIONAL MEDICATION. THE AS REPORTED 'PATIENT VESSEL DISSECTION' IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND PATIENT CONDITION AND IS LISTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE. THEREFORE, A PROBABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WAS ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A LITERATURE ARTICLE SUBMITTED FROM THE DEPARTMENT OF NEURORADIOLOGY, HEIDELBERG UNIVERSITY HOSPITAL GERMANY SUBMITTED AN ARTICLE ABOUT CONCOMITANT ACUTE ISCHEMIC STROKE AND UPPER EXTREMITY ARTERIAL OCCLUSION: FEASIBILITY OF MECHANICAL THROMBECTOMY OF THE UPPER LIMB USING NEURO INTERVENTIONAL DEVICES AND TECHNIQUES IN GERMANY, PUBLISHED IN 20 JULY 2021. DURING THE CRANIOCERVICAL OCCLUSION CASE THE PATIENT PRESENTED WITH HIGH GRADE STENOSIS IN THE RIGHT - SIDED OCCLUSION OF THE COMMON CAROTID ARTERY IT WAS TREATED WITH THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND STENTING OF A HIGH-GRADE STENOSIS. DURING CRANIOCERVICAL MECHANICAL THROMBECTOMY PROCEDURE A DISSECTION OF THE CERVICAL VERTEBRAL ARTERY (V2-SEGMENT), WHICH WAS TREATED PHARMACOLOGICALLY BY THE ADMINISTRATION OF HEPARIN AND ASPIRIN. DUE TO THE ONLY MINOR HEMODYNAMIC EFFECTS AND GOOD FLOW VIA THE CONTRALATERAL VERTEBRAL ARTERY, NO INTERVENTIONAL TREATMENT WAS NECESSARY. NO PATIENT CLINICAL CONSEQUENCES WERE REPORTED. NO OTHER INFORMATION IS AVAILABLE ABOUT THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A LITERATURE ARTICLE SUBMITTED FROM THE THE DEPARTMENT OF NEURORADIOLOGY, HEIDELBERG UNIVERSITY HOSPITAL GERMANY SUBMITTED AN ARTICLE ABOUT CONCOMITANT ACUTE ISCHEMIC STROKE AND UPPER EXTREMITY ARTERIAL OCCLUSION: FEASIBILITY OF MECHANICAL THROMBECTOMY OF THE UPPER LIMB USING NEUROINTERVENTIONAL DEVICES AND TECHNIQUES IN GERMANY, PUBLISHED IN 20 JULY 2021. DURING THE CRANIOCERVICAL OCCLUSION CASE THE PATIENT PRESENTED WITH HIGH GRADE STENOSIS IN THE RIGHT - SIDED OCCLUSION OF THE COMMON CAROTID ARTERY IT WAS TREATED WITH THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND STENTING OF A HIGH-GRADE STENOSIS. DURING CRANIOCERVICAL MECHANICAL THROMBECTOMY PROCEDURE A DISSECTION OF THE CERVICAL VERTEBRAL ARTERY (V2-SEGMENT), WHICH WAS TREATED PHARMACOLOGICALLY BY THE ADMINISTRATION OF HEPARIN AND ASPIRIN. DUE TO THE ONLY MINOR HEMODYNAMIC EFFECTS AND GOOD FLOW VIA THE CONTRALATERAL VERTEBRAL ARTERY, NO INTERVENTIONAL TREATMENT WAS NECESSARY. NO PATIENT CLINICAL CONSEQUENCES WERE REPORTED. NO OTHER INFORMATION IS AVAILABLE ABOUT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411062 UNKNOWN_NEUROVASCULAR_PRODUCT CATHETER, THROMBUS RETRIEVER NRY STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other