BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIOJET AVX THROMBECTOMY CATHETER

    MDR report key: 2757825 · Received September 20, 2012

    Report

    Report Number
    2183460-2012-00017
    Event Type
    Death
    Date Received
    September 20, 2012
    Date of Event
    August 22, 2012
    Report Date
    September 20, 2012
    Manufacturer
    BAYER INTERVENTIONAL, INC.
    Product Code
    DXE
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF A PT DEATH POST ANGIOJET THERAPY. THE PT IS A MALE OF UNK AGE AND MEDICAL HISTORY. THE PHYSICIAN HAD PERFORMED THROMBECTOMY ON A FISTULA WITH AN ANGIOJET ULTRA AVX THROMBECTOMY SET FOLLOWED BY BALLOON ANGIOPLASTY AND WAS PREPARING TO STENT A TIGHT SEGMENT. AS THEY WERE PREPPING THE STENT THE PT HAS O2 SATURATION CHANGES AND IRREGULAR HEARTBEAT LEADING TO A CODE BEING CALLED. AFTER REVIVING THE PT HE WAS TRANSPORTED TO THE PT FLOOR WHERE HE EXPIRED SOMETIME LATER THAT EVENING. THE (B)(4) SALES REP DISCUSSED THE CASE WITH THE PHYSICIAN WHO STATED HE FELT HE WOULD NOT CHANGE ANYTHING IN HIS TECHNIQUE OR THE USE OF THE ANGIOJET. THE PHYSICIAN NOTED THE CLOT BURDEN WAS MUCH LOWER THAN OTHER CASES HE HAS PERFORMED AND THE PT HAS AN ADDITIONAL STENOSIS WHICH WOULD HAVE PROTECTED ANY CLOT FROM MIGRATING TO THE LUNGS. THE CAUSE OF DEATH WAS LISTED AS PULMONARY EMBOLISM (PE) AS REPORTED BY HOSPITAL STAFF. HOWEVER IT WAS NOT WRITTEN ON ANY REPORT. IT IS NOTED THAT AN AUTOPSY WAS PERFORMED ON (B)(6) 2012, BUT WE HAVE NOT BEEN INFORMED OF THE ACTUAL CAUSE OF DEATH. EVEN THOUGH THE HOSPITAL STAFF STATED PE WAS THE CAUSE OF DEATH, THE PHYSICIAN HAD STATED THAT THE PT HAD ADDITIONAL STENOSIS WHICH WOULD HAVE PROTECTED ANY CLOT FROM MIGRATING TO THE LUNGS. IN ADDITION, THE COMPLAINT FORM DOCUMENTS THAT THE PHYSICIAN DOES NOT BELIEVE THE ANGIOJET DEVICE CAUSED OR CONTRIBUTED TO THE DEATH OR INJURY OF THE PT. THIS EVENT IS REPORTABLE SINCE THE PT'S O2 SATURATION CHANGES AND IRREGULAR HEARTBEAT LEAD TO A CODE BEING CALLED WHICH REQUIRED INTERVENTION TO REVIVE THE PT AS WELL AS THE SUBSEQUENT DEATH OF THE PT LATER THAT EVENING AND THE ASSOCIATION BETWEEN THE ANGIOJET DEVICE AND THE NOTED EVENT CANNOT BE CONCLUSIVELY RULED OUT EVEN THOUGH THE PHYSICIAN DID NOT BELIEVE THE DEVICE CONTRIBUTED TO THE PT'S DEATH. THE INTERVENTION TO ADDRESS THE PT'S CODE REQUIRES THIS EVENT TO BE REPORTED EVENT THOUGH THE RESULTS OF THE PT AUTOPSY RESULTS ARE UNK.

    Description of Event or Problem · 1

    AFTER PERFORMING AN ANGIOJET PROCEDURE ON A FISTULA UTILIZING AN AVX CATHETER, DR. (B)(6) BALLOONED AND WAS PREPARING TO STENT A TIGHT SEGMENT. AS THEY WERE PREPPING THE STENT THE PT HAD O2 SAT CHANGES AND IRREGULAR HEARTBEAT LEADING TO A CODE BEING CALLED. AFTER REVIVING THE PT HE WAS TRANSPORTED TO THE PT FLOOR, WHERE HE EXPIRED SOMETIME LATER THAT EVENING. AFTER DISCUSSING THE EVENT WITH DR. (B)(6) HE DID NOT FEEL HE WOULD CHANGE ANYTHING IN HIS TECHNIQUE OR THE USE OF THE ANGIOJET. HE NOTICED THE CLOT BURDEN WAS MUCH LOWER THAN OTHER CASES HE HAS PERFORMED AND THE PT HAD AN ADDITIONAL STENOSIS WHICH WOULD HAVE PROTECTED ANY CLOT FROM MIGRATING TO THE LUNGS. AN AUTOPSY WAS PERFORMED ON (B)(6), HOWEVER I WAS NOT INFORMED ON ACTUAL CAUSE OF DEATH. UPDATE: CAUSE OF DEATH LISTED AS PE, THIS WAS REPORTED BY STAFF AND NOT AN OFFICIAL WRITTEN REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET AVX THROMBECTOMY CATHETER EMBOLECTOMY CATHETER DXE BAYER INTERVENTIONAL, INC. 105039-001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death