BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 19096264 · Received April 12, 2024

    Report

    Report Number
    3001845648-2024-00167
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    April 10, 2023
    Report Date
    June 24, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    UDI-DI
    10827002528458
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: P050017/S006 SUPPLEMENTAL CANCELLATION REPORT IS BEING SUBMITTED DUE TO THE RECEIPT OF CLINICAL INPUT ON (B)(6)-2024 CONFIRMING THE STENT WAS NOT DEPLOYED INTO PATIENT¿S CEREBRAL AREA AND ISCHEMIC EVENT IS IRRELEVANT TO THE STENT PLACEMENT. FDA MDR REPORT IS NO LONGER REQUIRED AS THE COMPLAINT FILE IS BEING CANCELLED.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # P050017/S006. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    SUPPLEMENTAL CANCELLATION REPORT IS BEING SUBMITTED DUE TO THE RECEIPT OF CLINICAL INPUT ON (B)(6)2024 CONFIRMING THE STENT WAS NOT DEPLOYED INTO PATIENT¿S CEREBRAL AREA AND ISCHEMIC EVENT IS IRRELEVANT TO THE STENT PLACEMENT. COMPLAINT FILE IS BEING CANCELLED.

    Description of Event or Problem · 0

    TRANSITORIC ISCHEMIC EVENT MCA-TERRITORY LEFT WITH MOTORIC APHASIA AND FACIAL PARESIS RIGHT SIDE FOR 2H DURATION, SELF LIMITING, PRE-INDEX PROCEDURE KNOWN CHRONIC OCCLUSION OF LEFT ICA PRESENTATION TIA IN LEFT MCA TERRITORY WITH PRE-INDEX PROCEDURE KNOWN HISTORY OF CHRONIC LEFT ICA OCCLUSION. LAB WORK UP SHOWED HYPERCHROMATIC MICROCYTIC ANAEMIA WITH HB 5,6 MG/DL DUE TO CHRONIC ULCERATIVE GASTRIC BLEED PATIENT HAD A BLEEDING GASTRIC ULCER EITHER UNKNOWN PRE-EXISTING AT INDEX PROCEDURE OR AFTER THE INDEX PROCEDURE. PATIENT HAD TAKEN AN INTENSIFIED DUAL ANTIPLATELET MEDICATION SCHEME ASS AND CLOPIDOGREL + XARELTO AND NORMALLY ONLY TAKES ASS AND XARELTO (WE RECOMMENDED CLOPIDOGREL AND XARELTO AFTER A PRECURING RIGHT LEG PTA ON (B)(6) 2023. EITHER THE PRECURING PROCEDURE OR THE INDEX PROCEDURE MIGHT HAVE LED TO CONFUSION WITH THE MEDICATION PLAN WHICH MIGHT HAVE LED TO AN OVER-MEDICATION WHICH MIGHT HAVE WORSENED OR CAUSED A GASTRIC BLEEDING EVENT. BLEEDING EVENT DUE TO A GASTRIC ULCER (NO KNOWN HISTORY OF GASTROSCOPY) SO EITHER DE-NOVO OR PRE-EXISTING WITH POSSIBLE WORSENING OR CAUSE BY AN INTENSIFIED ANTI-PLATELET AND ANTICOAGULATION SCHEME. THE USUAL REGIME OF ASS AND XARELTO WAS CHANGED ON (B)(6) 2023 TO CLOPIDOGREL AND XARELTO AND KEPT DURING AND PRESCRIBED AFTER THE INDEX PROCEDURE IN (B)(6) 2023. PATIENT TOOK TOO MUCH ANTIPLATELET AND PRESENTED WITH A CHRONIC GASTRIC BLEEDING UNDER ASS AND CLOPIDOGREL AND XARELTO. OUR ENDOVASCULAR PROCEDURES MIGHT HAVE LED TO CONFUSION WITH THE MEDICATION REGIME EVEN IF WE CORRECTLY DESCRIBED THE PLAN, ASS IS OTC IN GERMANY SO THERE WAS NO POSSIBLE CHECK FOR AN ACCIDENTAL ASS-SELF-MEDICATION. AT THE TIME OF PRESENTATION ENDOSCOPIC DIAGNOSIS OF A CHRONIC BUT HEALING, NOT ACTIVELY BUT PAST BLEEDING GASTRIC ULCER WHICH LED TO SEVERE ANAEMIA. PATIENT OUTCOME: MODIFICATION OF CURRENT ANTIPLATELET DRUGS. BLOOD TRANSFUSION. 5 DAYS PAUSATION OF CLOPIDOGREL FOR PLANNED GASTROSCOPIC BIOPSY. EVENT IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509861 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD C1968094 10827002528458

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention| H