BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 13024965 · Received December 17, 2021

    Report

    Report Number
    3008114965-2021-00719
    Event Type
    Injury
    Date Received
    December 17, 2021
    Date of Event
    May 14, 2018
    Report Date
    December 17, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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: FORBRIG R, LOCKAU H, FLOTTMANN F, BOECKH-BEHRENS T, KABBASCH C, PATZIG M, MPOTSARIS A, FIEHLER J, LIEBIG T, THOMALLA G, ONUR OA, WUNDERLICH S, KREISER K, HERZBERG M, WOLLENWEBER FA, PROTHMANN S, DORN F. INTRACRANIAL RESCUE STENT ANGIOPLASTY AFTER STENT-RETRIEVER THROMBECTOMY : MULTICENTER EXPERIENCE. CLIN NEURORADIOL. 2019 SEP;29(3):445-457. DOI: 10.1007/S00062-018-0690-4. EPUB 2018 MAY 14. PMID: 29761219. 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. THE ARTICLE CANNOT BE ATTACHED TO DUE ELECTRONIC FILE SIZE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: FORBRIG R, LOCKAU H, FLOTTMANN F, BOECKH-BEHRENS T, KABBASCH C, PATZIG M, MPOTSARIS A, FIEHLER J, LIEBIG T, THOMALLA G, ONUR OA, WUNDERLICH S, KREISER K, HERZBERG M, WOLLENWEBER FA, PROTHMANN S, DORN F. INTRACRANIAL RESCUE STENT ANGIOPLASTY AFTER STENT-RETRIEVER THROMBECTOMY : MULTICENTER EXPERIENCE. CLIN NEURORADIOL. 2019 SEP;29(3):445-457. DOI: 10.1007/S00062-018-0690-4. EPUB 2018 MAY 14. PMID: 29761219. OBJECTIVE AND METHODS: TO PRESENT RETROSPECTIVE MULTICENTER STUDY AND REPORT ON EXPERIENCE WITH RSA IN PATIENTS WITH ACUTE INTRACRANIAL ANTERIOR AND POSTERIOR CIRCULATION LAO AND IMMEDIATE RE-OCCLUSION AFTER INITIALLY SUCCESSFUL SRT. IN A RETROSPECTIVE ANALYSIS, ALL PATIENTS WITH ACUTE INTRACRANIAL LAO OF THE ANTERIOR AND POSTERIOR CIRCULATION, WHO UNDERWENT RSA BETWEEN NOVEMBER 2012 AND AUGUST 2017, WERE IDENTIFIED FROM THE STROKE DATABASES OF FOUR TERTIARY STROKE CENTERS. IN ALL CENTERS, A TOTAL OF 1617 INTRACRANIAL THROMBECTOMIES WERE CONDUCTED IN THIS TIME PERIOD. AFTER FILTERING FOR INCLUSION/EXCLUSION DATA REQUIREMENTS, A TOTAL OF 34 PATIENTS WERE INCLUDED IN THE ANALYSIS. MEAN AGE WAS 67 YEARS AND 11 PATIENTS (32%) WERE FEMALE. TABLE 1 SUMMARIZES THE PATIENTS¿ BASELINE CHARACTERISTICS, INTERVENTIONAL DATA, AND CLINICAL OUTCOME. WITHIN THE TABLE, FIVE PATIENTS WERE IDENTIFIED WITH CNV PRODUCTS AND ADVERSE EVENTS: PATIENT #1, #4, #6, #19, AND #28. THIS COMPLAINT CAPTURES THESE PATIENTS. 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 TO THESE PATIENTS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: PATIENT #2 IS (B)(6) YEARS OLD FEMALE WITH M1 OCCLUSION SITE, RECEIVED AN ENTERPRISE STENT AND EXPERIENCED EARLY POST-INTERVENTIONAL OCCLUSION AT 24 HOURS AT THE TREATED SITE, NO INTRACRANIAL HEMORRHAGE IN THE ACUTE POST-INTERVENTIONAL PHASE. PATIENT #4 IS A (B)(6) YEARS OLD FEMALE WITH DISTAL ICA OCCLUSION SITE, RECEIVED AN ENTERPRISE STENT AND EXPERIENCED EARLY POST-INTERVENTIONAL OCCLUSION AT 24 HOURS AT THE TREATED SITE, EXPERIENCED INTRACRANIAL HEMORRHAGE IN THE ACUTE POST-INTERVENTIONAL PHASE. PATIENT #6 IS A (B)(6) YEARS OLD FEMALE WITH M1 OCCLUSION SITE, RECEIVED AN ENTERPRISE STENT AND EXPERIENCED EARLY POST-INTERVENTIONAL OCCLUSION AT 24 HOURS AT THE TREATED SITE, NO INTRACRANIAL HEMORRHAGE IN THE ACUTE POST-INTERVENTIONAL PHASE. PATIENT #19 IS A (B)(6) YEARS OLD MALE WITH BA OCCLUSION SITE, RECEIVED AN ENTERPRISE STENT AND EXPERIENCED EARLY POST-INTERVENTIONAL OCCLUSION AT 24 HOURS AT THE TREATED SITE, NO INTRACRANIAL HEMORRHAGE IN THE ACUTE POST-INTERVENTIONAL PHASE. PATIENT #28 IS A (B)(6) YEARS OLD MALE WITH PETROUS ICA OCCLUSION SITE, RECEIVED AN ENTERPRISE STENT AND EXPERIENCED RESTENOSIS GREATER THAN 50% AFTER 3 MONTHS, NO INTRACRANIAL HEMORRHAGE IN THE ACUTE POST-INTERVENTIONAL PHASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1931671 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening