BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXOR ANSEL GUIDING SHEATH

    MDR report key: 4194001 · Received October 8, 2014

    Report

    Report Number
    1820334-2014-00496
    Event Type
    Death
    Date Received
    October 8, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DESCRIPTION: STILL UNDER INVESTIGATION. AS OF (B)(6) 2014, IT WAS CONFIRMED THAT THE PIECE OF STENT PUSHED TO THE SFA AND SFA STILL REMAINED BEING STUCK IN THE PTX. ALTHOUGH PTX STENTS WERE EXPANDED WITH BALLOON DILATION, FLOW IN THE BACK KNEE CANNOT BE CONFIRMED DUE TO TRAVELED BLOOD CLOTS. (THROMBOTIC OCCLUSION HAD BEEN ORIGINALLY OBSERVED). ADD'L TREATMENT INCLUDING BYPASS SURGERY WILL BE DISCUSSED WITH THE PT'S FAMILY ON (B)(6) 2014. AMPUTATION WILL ALSO BE CONSIDERED DUE TO OLD AGE AND ULCERATION IN THE HEEL. (B)(6) 2014, ADD'L INFO PROVIDED. BASED ON THE INFO PROVIDED ON (B)(6) 2014 BY THE PHYSICIAN, THROMBOLYSIS WAS PERFORMED AS A RESULT, AND BLOOD FLOW IN THE BACK KNEE REVIVED. (B)(6) 2014: ADD'L INFO PROVIDED, THE PHYSICIAN STATES THAT BOTH BLOOD CLOTS WHICH BLOCKED THE BLOOD FLOW IN THE BACK KNEE AND SUBSEQUENT THROMBOLYSIS WERE NOT RELATED TO PTX DEVICES. THE PHYSICIAN DID NOT THINK THE EVENT OCCURRED DUE TO THE DEVICE. THE REP COMMENTED THAT THE PHYSICIAN DOES NOT STATE THAT THE DEVICES WERE DEFECTIVE WHICH CAUSED THE EVENT. HOWEVER, BECAUSE AMPUTATION IS CONSIDERED IN THE FUTURE DUE TO THE EVENT AND THE PT HAS PTXS IMPLANTED. I REPORTED THE EVENT TAKING IT SERIOUSLY. THE REP EXPLAINED TO THE PHYSICIAN ABOUT NECESSITY OF PRE-DILATION FOR THE STENT PLACEMENT, AND HE WOULD FOLLOW THE INSTRUCTION NEXT TIME. (B)(6) 2014, ADD'L INFO PROVIDED: THE PT DIED ON (B)(6) 2014 DUE TO UNK CAUSE WHICH IS NOT RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, ONE ZILVER635 STENT WAS PLACED IN THE LEFT CIA. SINCE THE PROCEDURE WAS CONDUCTED WITHOUT PRE-DILATION, POST-DILATION WAS PERFORMED. HOWEVER, A BALLOON DEVICE FOR THE POST-DILATION WAS CAUGHT ON THE ZIV6 STENT AND THE STENT LOCKED LIKE BEING DEFORMED. ON THE (B)(6) 2014, STENT PLACEMENT WITH THREE PTX STENTS WERE PERFORMED IN THE RIGHT SFA WITH BI-DIRECTIONAL APPROACH, CROSS-OVER APPROACH FROM THE LEFT GROIN AND FROM BACK OF THE RIGHT KNEE. THE PT WAS NOT SUITABLE FOR THE PROCEDURE SINCE THE LESION WAS LONG, BUT NOT BYPASS SURGERY BUT EVT WAS SELECTED DUE TO OLD AGE. DURING THE PROCEDURE, RADIFOCUS AND AN ANGIO CATHETER WERE ADVANCED THROUGH MESH OF THE DEFORMED ZILVER635 PLACED ON (B)(6) 2014. IT WAS WHEN THE PHYSICIAN FIRST NOTICED THAT THE ZILVER635 WAS DAMAGED. AFTER CROSS-OVER APPROACH WAS MADE WITH THE ANGIO CATHETER. IT WAS CHANGED TO AN ANSEL SHEATH AND ADVANCED THROUGH THE MESH AS WELL. DURING ADVANCEMENT, DILATOR OF THE ANSEL COULD PASS WITHOUT DAMAGE BUT DAMAGE IN THE ANSEL SHEATH TIP WAS OBSERVED. THEREFORE, WHEN THE PHYSICIAN WAS ADVANCING DELIVERY SYSTEMS OF THE PTXS THROUGH THE ANSEL SHEATH, HE ENCOUNTERED STRONG RESISTANCE DUE TO DENT OF THE SHEATH TIP. (DESPITE THE RESISTANCE DURING ADVANCEMENT OF THE DELIVERY SYSTEM INTO THE SHEATH, EACH STENT COULD BE DEPLOYED WITHOUT DIFFICULTY.) ALSO, WHEN THE ANSEL WAS PASSING THROUGH THE MESH, IT BROKE THE ZILVER635, AND SEGMENT OF THE STENT WAS DELIVERED TO THE RIGHT CFA BY BEING PUSHED BY THE ANSEL. THEN, SINCE THE PHYSICIAN THOUGHT IT WOULD BE IMPOSSIBLE TO RETRIEVE THE SEGMENT, THE SEPARATED SEGMENT WAS ADVANCED TO THE SFA AND PUSHED TOWARD PTX WITH A BALLOON NOT TO MIGRATE. THE PROCEDURE WAS FINISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633274 FLEXOR ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA F4373611

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention