BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 13043062 · Received December 20, 2021

    Report

    Report Number
    3008114965-2021-00753
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    December 13, 2020
    Report Date
    December 20, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH REPORT (B)(4) UNDER MRN 3008114965-2021-00753 IS BEING RETRACTED. THE AUTHOR HAS CONFIRMED THAT THE ADVERSE EVENT WAS NOT RELATED TO JNJ DEVICES. RETRACTION OF (B)(4) UNDER MRN 3008114965-2021-00753.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: LU X, LI C, QU C, HUANG J, WANG Q, QIU B, WANG C, LI S, XU H, LIU Y. A HIGH RESOLUTION MRI STUDY OF THE RELATIONSHIP BETWEEN PLAQUE ENHANCEMENT AND PERFORATOR STROKE AFTER STENTING FOR SYMPTOMATIC VERTEBROBASILAR ARTERY STENOSIS. J STROKE CEREBROVASC DIS. 2021 MAR;30(3):105558. DOI: 10.1016/J.JSTROKECEREBROVASDIS.2020.105558. EPUB 2020 DEC 18. PMID: 33348247. 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: LU X, LI C, QU C, HUANG J, WANG Q, QIU B, WANG C, LI S, XU H, LIU Y. A HIGH RESOLUTION MRI STUDY OF THE RELATIONSHIP BETWEEN PLAQUE ENHANCEMENT AND PERFORATOR STROKE AFTER STENTING FOR SYMPTOMATIC VERTEBROBASILAR ARTERY STENOSIS. J STROKE CEREBROVASC DIS. 2021 MAR;30(3):105558. DOI: 10.1016/J.JSTROKECEREBROVASDIS.2020.105558. EPUB 2020 DEC 18. PMID: 33348247. OBJECTIVE AND METHODS: AUTHORS INVESTIGATED WHETHER PERFORATOR STROKE AFTER VERTEBROBASILAR ARTERIAL STENTING IS ASSOCIATED WITH PLAQUE ENHANCEMENT IN PATIENTS WITH SEVERE VERTEBROBASILAR ARTERY STENOSIS. AUTHORS STUDIED PATIENTS WITH SYMPTOMATIC VERTEBROBASILAR ARTERIAL STENOSIS WHO UNDERWENT STENTING FROM JANUARY 2017 TO JULY 2020. PATIENTS WHO UNDERWENT HIGH RESOLUTION MAGNETIC RESONANCE IMAGING WERE RECRUITED AMONG THEM. DEMOGRAPHIC DATA, RISK FACTORS OF ATHEROSCLEROSIS, PROCEDURE DETAILS, AND CHARACTERISTICS OF IMAGING WERE EXTRACTED FROM ELECTRONIC HEALTH RECORDS AND IMAGING DATA. PLAQUE FEATURES WERE INVESTIGATED BY HIGH RESOLUTION MAGNETIC RESONANCE IMAGING. IT IS NOTED THAT ENTERPRISE IS MENTIONED ONLY WITHIN A CAPTION OF ILLUSTRATION AND CAPTURED IN THIS COMPLAINT. 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. NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS (FROM THE ARTICLE'S STUDY): A (B)(6) MALE PATIENT EXPERIENCED A STROKE AT BRAINSTEM WITHIN 12 HOURS AFTER STENTING WITH ENTERPRISE STENT (FIGURE 2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941543 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown