BEUDAMED
    FDA Adverse Event Death Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 13026409 · Received December 17, 2021

    Report

    Report Number
    3008114965-2021-00734
    Event Type
    Death
    Date Received
    December 17, 2021
    Date of Event
    August 15, 2014
    Report Date
    December 17, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: GAWLITZA M, FRITZSCH D, QUÄSCHLING U, HOBOHM C, HOFFMANN KT, LOBSIEN D. MECHANICAL THROMBECTOMY IN PATIENTS WITH ACUTE VERTEBROBASILAR OCCLUSION USING THE TREVO DEVICE: A SINGLE-CENTRE EXPERIENCE. NEURORADIOLOGY. 2014 NOV;56(11):977-83. DOI: 10.1007/S00234-014-1417-0. EPUB 2014 AUG 15. PMID: 25119255. THE PRODUCT CATALOG AND LOT NUMBERS ARE NOT AVAILABLE / NOT REPORTED. THE UNIQUE IDENTIFIER (UDI) AND EXPIRATION DATE OF THE DEVICE IS NOT KNOWN. THE INITIAL REPORTER PHONE IS NOT AVAILABLE. THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. DUE TO THE NATURE OF THE COMPLAINT, THE DEVICE (S) WERE NOT RETURNED FOR ANALYSIS NOR WAS THE STERILE LOT NUMBERS PROVIDED IN ORDER TO CONDUCT A LOT HISTORY REVIEW. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: GAWLITZA M, FRITZSCH D, QUÄSCHLING U, HOBOHM C, HOFFMANN KT, LOBSIEN D. MECHANICAL THROMBECTOMY IN PATIENTS WITH ACUTE VERTEBROBASILAR OCCLUSION USING THE TREVO DEVICE: A SINGLE-CENTRE EXPERIENCE. NEURORADIOLOGY. 2014 NOV;56(11):977-83. DOI: 10.1007/S00234-014-1417-0. EPUB 2014 AUG 15. PMID: 25119255. OBJECTIVE AND METHODS: THE PURPOSE OF THE STUDY IS TO INVESTIGATE THE EFFICACY AND SAFETY OF MECHANICAL THROMBECTOMY IN PATIENTS WITH ACUTE VERTEBROBASILAR ARTERY OCCLUSION (VBAO) USING A NON-CERENOVUS DEVICE. TWENTY PATIENTS DIAGNOSED WITH VBAO UNDERWENT DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) WITH THE INTENTION TO PERFORM MECHANICAL THROMBECTOMY WITH STENT-RETRIEVERS BETWEEN AUGUST 2011 AND OCTOBER 2013. TABLE 1 PROVIDES DEMOGRAPHIC INFORMATION FOR 16 PATIENTS THAT WERE INCLUDED IN THE STUDY. PATIENT NO 1 AND NO 10 ARE NOTED TO HAVE ENTERPRISE STENTS WITH PATIENT NO 1 EXPERIENCING AN ADVERSE EVENT, ARTICLE NARRATIVE PROVIDES DETAILS OF THE ADVERSE EVENT. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ENTERPRISE STENT. OTHER CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. CONCOMITANT NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: TREVO STENTRIEVER (STRYKER). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: PATIENT NO 1 , (B)(6) YEARS OLD FEMALE PATIENT WITH DISTAL OCCLUSION SITE RECEIVED THROMBECTOMY PROCEDURE THAT INCLUDED AN ENTERPRISE STENT AND DIED FROM WIRE PERFORATION RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928948 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Death