BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 13026278 · Received December 17, 2021

    Report

    Report Number
    3008114965-2021-00733
    Event Type
    Injury
    Date Received
    December 17, 2021
    Date of Event
    October 29, 2016
    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:KURRE W, BANSEMIR K, AGUILAR PÉREZ M, MARTINEZ MORENO R, SCHMID E, BÄZNER H, HENKES H. ENDOVASCULAR TREATMENT OF ACUTE INTERNAL CAROTID ARTERY DISSECTIONS: TECHNICAL CONSIDERATIONS, CLINICAL AND ANGIOGRAPHIC OUTCOME. NEURORADIOLOGY. 2016 DEC;58(12):1167-1179. DOI: 10.1007/S00234-016-1757-Z. EPUB 2016 OCT 29. PMID: 27796447. 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. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. 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:KURRE W, BANSEMIR K, AGUILAR PÉREZ M, MARTINEZ MORENO R, SCHMID E, BÄZNER H, HENKES H. ENDOVASCULAR TREATMENT OF ACUTE INTERNAL CAROTID ARTERY DISSECTIONS: TECHNICAL CONSIDERATIONS, CLINICAL AND ANGIOGRAPHIC OUTCOME. NEURORADIOLOGY. 2016 DEC;58(12):1167-1179. DOI: 10.1007/S00234-016-1757-Z. EPUB 2016 OCT 29. PMID: 27796447. OBJECTIVE AND METHODS: WHEREAS SCIENTIFIC EVALUATION OF ENDOVASCULAR THERAPY (EVT) IN TANDEM LESIONS WITH UNDERLYING ATHEROSCLEROSIS OR IN MIXED POPULATIONS IS INCREASING, CLINICAL DATA FOCUSING ON EVT OF ACUTE INTERNAL CAROTID ARTERY DISSECTION (A-ICAD) ARE SPARSE. THE AUTHORS OUTLINE THEIR EXPERIENCE FOCUSING ON TECHNICAL ASPECTS, CLINICAL AND ANGIOGRAPHIC OUTCOME. 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: ASCENT BALLOON NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: MULTIPLE CATHETERS, STENTS, MICRO STENTS, FLOW DIVERTERS, BALLOONS, THROMBECTOMY DEVICES AND RETRIEVERS. REFER TO TABLE 1 ON PAGE 1169 OF ARTICLE FOR BRAND NAMES AND MANUFACTURERS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: 13 THROMBUS FORMATIONS TREATED BY IV GPIIB/IIIA INHIBITORS AND OTHER INTRAPROCEDURAL INTERVENTIONS. 15 EMBOLISMS TREATED WITH RECANALIZATION MEASURES. 2 INTRAPROCEDURAL HEMORRHAGES. 3 INTRACRANIAL DISSECTIONS TREATED BY STENT IMPLANTATION. ONE SELF-LIMITING CAROTID FISTULA. ONE EXTRAVASATION OF CERVICAL CAROTID ARTERY COVERED BY A STENT-GRAFT. ONE DETACHMENT OF A STENT RETRIEVER DUE TO ENTANGLING IN A CERVICAL STENT. ALTHOUGH ADVERSE EVENTS WERE NOTED AND THE ARTICLE PROVIDES A TABLE OF INFORMATION INCLUDING PATIENT IDENTIFIERS, THE ARTICLE DOES NOT PROVIDE SUFFICIENT INFORMATION TO DETERMINE WHICH MANUFACTURER'S MEDICAL DEVICE IS ASSOCIATED WITH THE ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926930 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening ASCENT BALLOON| BALLOONS| FLOW DIVERTERS| MICRO STENTS| MULTIPLE CATHETERS| RETRIEVERS| STENTS| THROMBECTOMY DEVICES