BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 12941716 · Received December 6, 2021

    Report

    Report Number
    3008114965-2021-00632
    Event Type
    Injury
    Date Received
    December 6, 2021
    Date of Event
    October 29, 2021
    Report Date
    December 6, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE CITATION IS AS FOLLOWS: YU Y, YAN L, LOU Y, CUI R, KANG K, JIANG L, MO D, GAO F, WANG Y, LOU X, MIAO Z, MA N. MULTIPLE PREDICTORS OF IN-STENT RESTENOSIS AFTER STENT IMPLANTATION IN SYMPTOMATIC INTRACRANIAL ATHEROSCLEROTIC STENOSIS. J NEUROSURG. 2021 OCT 29:1-10. DOI: 10.3171/2021.6.JNS211201. EPUB AHEAD OF PRINT. PMID: 34715652. 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. THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (VRD) IS INTENDED FOR USE WITH OCCLUSIVE DEVICES IN THE TREATMENT OF INTRACRANIAL ANEURYSMS. IT IS NOT INTENDED FOR USE AS A STAND-ALONE DEVICE, I.E., WITHOUT SUBSEQUENT COIL EMBOLIZATION OF THE ANEURYSM. THE STENTS WERE USED OFF-LABEL FOR SYMPTOMATIC INTRACRANIAL ATHEROSCLEROTIC STENOSIS. WITH THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENTS. HOWEVER, THERE ARE PATIENT, PROCEDURAL, AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED. THERE IS NO INDICATION THAT THE DEVICE (S) MALFUNCTIONED OR THAT THE EVENTS WERE RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. 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. THE CITATION IS AS FOLLOWS: YU Y, YAN L, LOU Y, CUI R, KANG K, JIANG L, MO D, GAO F, WANG Y, LOU X, MIAO Z, MA N. MULTIPLE PREDICTORS OF IN-STENT RESTENOSIS AFTER STENT IMPLANTATION IN SYMPTOMATIC INTRACRANIAL ATHEROSCLEROTIC STENOSIS. J NEUROSURG. 2021 OCT 29:1-10. DOI: 10.3171/2021.6.JNS211201. EPUB AHEAD OF PRINT. PMID: 34715652. OBJECTIVE AND METHODS: THIS STUDY AIMED TO IDENTIFY PREDICTORS OF INTRACRANIAL IN-STENT RESTENOSIS (ISR) AFTER STENT PLACEMENT IN SYMPTOMATIC INTRACRANIAL ATHEROSCLEROTIC STENOSIS (ICAS). THE AUTHORS RETROSPECTIVELY COLLECTED DATA FROM CONSECUTIVE PATIENTS WHO SUFFERED FROM SYMPTOMATIC ICAS AND UNDERWENT SUCCESSFUL STENT PLACEMENT IN BEIJING TIANTAN HOSPITAL. ELIGIBLE PATIENTS WERE CLASSIFIED INTO ¿ISR,¿ ¿INDETERMINATE ISR,¿ OR ¿NO-ISR¿ GROUPS BY FOLLOW-UP DIGITAL SUBTRACTION ANGIOGRAPHY OR CT ANGIOGRAPHY. 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: TRANSCEND 0.014-INCH MICROWIRE, GATEWAY BALLOON, NEUROFORM EZ STENT, WINGSPAN STENT, APOLLO BALLOON-MOUNTED STENT ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: THERE WERE 8 CASES OF IN-STENT RESTENOSIS (ISR) ASSOCIATED WITH THE ENTERPRISE STENT. ISR WAS DEFINED AS > 50% STENOSIS WITHIN OR IMMEDIATELY ADJACENT (WITHIN 5 MM) OF THE IMPLANTED STENT AND > 20% ABSOLUTE LUMINAL LOSS. COMPLICATIONS WITHIN 30 DAYS WERE RECORDED INCLUDING HYPERPERFUSION SYNDROME, PERFORATOR STROKE, AND ACUTE CEREBRAL THROMBOSIS. THERE WERE A TOTAL OF 9 CASES OF HYPERPERFUSION SYNDROME (2 ISR, 2 INDETERMINATE ISR, AND 5 NO ISR), 13 PERFORATOR STROKES (2 ISR, 7 INDETERMINATE ISR, AND 4 NO ISR), AND 3 ACUTE CEREBRAL THROMBOSIS (0 ISR, 2 INDETERMINATE ISR, AND 1 NO ISR). THERE WERE A TOTAL OF 97 RECURRENT STROKES (42 ISR, 35 INDETERMINATE ISR, AND 20 NO ISR) AND 13 DEATHS (1 ISR, 8 INDETERMINATE ISR, AND 4 NO ISR). MEDIAN TIME TO RECURRENT STROKE WAS 13.5 MONTHS - 18.0 MONTHS. THERE IS INSUFFICIENT INFORMATION WITHIN THE TEXT OF THIS ARTICLE TO IDENTIFY WHICH DEVICES (S) (CERENOVUS OR NON-CERENOVUS) ARE ASSOCIATED WITH THE REPORTED COMPLICATIONS. EXACT QUANTITIES CANNOT BE DETERMINED ACCURATELY AS THE ARTICLE DOES NOT PROVIDE ADEQUATE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837888 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening APOLLO BALLOON-MOUNTED STENT| GATEWAY BALLOON| NEUROFORM EZ STENT| TRANSCEND 0.014-INCH MICROWIRE| WINGSPAN STENT