BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 13079102 · Received December 23, 2021

    Report

    Report Number
    3008114965-2021-00778
    Event Type
    Injury
    Date Received
    December 23, 2021
    Date of Event
    August 7, 2012
    Report Date
    December 23, 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. THE CITATION IS AS FOLLOWS: VAJDA Z, GÜTHE T, PEREZ MA, KURRE W, SCHMID E, BÄZNER H, HENKES H. PREVENTION OF INTRACRANIAL IN-STENT RESTENOSES: PREDILATATION WITH A DRUG ELUTING BALLOON, FOLLOWED BY THE DEPLOYMENT OF A SELF-EXPANDING STENT. CARDIOVASC INTERVENT RADIOL. 2013 APR;36(2):346-52. DOI: 10.1007/S00270-012-0450-9. EPUB 2012 AUG 7. PMID: 22869043; PMCID: PMC3595472. 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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE CITATION IS AS FOLLOWS: VAJDA Z, GÜTHE T, PEREZ MA, KURRE W, SCHMID E, BÄZNER H, HENKES H. PREVENTION OF INTRACRANIAL IN-STENT RESTENOSES: PREDILATATION WITH A DRUG ELUTING BALLOON, FOLLOWED BY THE DEPLOYMENT OF A SELF-EXPANDING STENT. CARDIOVASC INTERVENT RADIOL. 2013 APR;36(2):346-52. DOI: 10.1007/S00270-012-0450-9. EPUB 2012 AUG 7. PMID: 22869043; PMCID: PMC3595472. OBJECTIVE AND METHODS: IN THIS STUDY, FEASIBILITY, SAFETY, AND EFFICACY OF ANGIOPLASTY USING A DRUG-ELUTING BALLOON (DEB) FOLLOWED BY THE IMPLANTATION OF A SELF-EXPANDING STENT (ENTERPRISE) WERE EVALUATED FOR THE TREATMENT OF INTRACRANIAL ATHEROSCLEROTIC DISEASE (ICAD) LESIONS, FIFTY-TWO PATIENTS UNDERWENT STENTING OF HIGH-GRADE ICAD LESIONS BETWEEN FEBRUARY 2010 AND NOVEMBER 2011 IN A SINGLE CENTER. LOT, MODEL AND CATALOG NUMBERS ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ENTERPRISE STENT CONCOMITANT CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: RAPIDTRANSIT MICROCATHETER, PROWLER SELECT PLUS MICROCATHETER CONCOMITANT NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: SILVERSPEED-14 MICROWIRE (COVIDIEN/EV3), TRAXCESS14 MICROWIRE (TERUMO), RYUJIN PLUS BALLOON (TERUMO), SEQUENT PLEASE DRUG ELUTING BALLOON (B. BRAUN), DIOR DRUG ELUTING BALLOON (EUROCOR). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: A (B)(6) MALE PATIENT EXPERIENCED A NEW INFARCTION OF THE DORSOLATERAL MEDULLA, PERMANENT DEFICIT. A (B)(6) MALE PATIENT EXPERIENCED A NEW INFARCTION IN THE PONS, PERMANENT DEFICIT. A (B)(6) MALE PATIENT EXPERIENCED REINFARCTION IN THE PONS, PERMANENT DEFICIT, EXITUS . A (B)(6) FEMALE PATIENT EXPERIENCED TWO SMALL LACUNAE IN THE ANTERIOR CEREBRAL ARTERY (ACA) AREA. A (B)(6) FEMALE PATIENT EXPERIENCED BASAL GANGLIA ISCHEMIA TWO DAYS LATER, CLOPIDOGREL RESISTANCE . AN (B)(6) MALE PATIENT EXPERIENCED NEW SUBCORTICAL DIFFUSION WEIGHTED IMAGING (DWI) LESION BILATERAL . A (B)(6) FEMALE PATIENT EXPERIENCED SMALL DWI LESIONS IN PONS. A (B)(6) MALE PATIENT EXPERIENCED SMALL DWI LESIONS IN CEREBELLUM . A (B)(6) FEMALE EXPERIENCED A SUBARACHNOID HEMORRHAGE (SAH) AROUND STENTED INTERNAL CAROTID ARTERY (ICA) SEGMENT. A (B)(6) MALE PATIENT EXPERIENCED SMALL DWI LESION IN PONS. A (B)(6) FEMALE PATIENT EXPERIENCED STENT THROMBUS DURING THE INTERVENTION, IMMEDIATELY RECANALIZED, SMALL PETECHIAE IN BASAL GANGLIA. THERE WAS ONE ASYMPTOMATIC IN-STENT RECURRENT STENOTIC LESION DEVELOPED IN THE M1 SEGMENT OF A LEFT MIDDLE CEREBRAL ARTERY (MCA) 3 MONTHS AFTER THE ANGIOPLASTY WITH A DIOR DEB AND IMPLANTATION OF AN ENTERPRISE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1971999 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening DIOR DRUG ELUTING BALLOON (EUROCOR)| PROWLER SELECT PLUS MICROCATHETER| RAPIDTRANSIT MICROCATHETER| RYUJIN PLUS BALLOON (TERUMO)| SEQUENT PLEASE DRUG ELUTING BALLOON (B. BRAUN)| SILVERSPEED-14 MICROWIRE (COVIDIEN/EV3)| TRAXCESS14 MICROWIRE (TERUMO)