BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 16958737 · Received May 18, 2023

    Report

    Report Number
    3008114965-2023-00317
    Event Type
    Injury
    Date Received
    May 18, 2023
    Date of Event
    January 15, 2013
    Report Date
    May 18, 2023
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: GALAL A, BAHRASSA F, DALFINO JC, BOULOS AS. STENT-ASSISTED TREATMENT OF UNRUPTURED AND RUPTURED INTRACRANIAL ANEURYSMS: CLINICAL AND ANGIOGRAPHIC OUTCOME. BR J NEUROSURG. 2013 OCT;27(5):607-16. DOI: 10.3109/02688697.2012.757292. EPUB 2013 JAN 15. PMID: 23316930. SECTION D.4: THE PRODUCT CATALOG AND LOT NUMBERS ARE NOT AVAILABLE / NOT REPORTED. THE UNIQUE IDENTIFIER (UDI) AND EXPIRATION DATE OF THE DEVICE IS NOT KNOWN. SECTION E.1: THE INITIAL REPORTER PHONE IS NOT AVAILABLE / REPORTED. SECTION H.4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. SINCE THIS EVENT REQUIRED MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION FOR TREATMENT OR PREVENTION OF PERMANENT DAMAGE TO THE PATIENT, THE EVENT IS BEING REPORTED TO THE US FDA AS A CONSERVATIVE MEASURE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: GALAL A, BAHRASSA F, DALFINO JC, BOULOS AS. STENT-ASSISTED TREATMENT OF UNRUPTURED AND RUPTURED INTRACRANIAL ANEURYSMS: CLINICAL AND ANGIOGRAPHIC OUTCOME. BR J NEUROSURG. 2013 OCT;27(5):607-16. DOI: 10.3109/02688697.2012.757292. EPUB 2013 JAN 15. PMID: 23316930. OBJECTIVE AND METHODS: THIS RETROSPECTIVE STUDY INCLUDES 43 PATIENTS WITH WIDE-NECKED, FUSIFORM OR BLISTER ANEURYSMS TREATED WITH STENT-ASSISTED COILING OR STENT ALONE. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE IS 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: NEURON DELIVERY CATHETER 6F GUIDE CATHETER OR A 6F GUIDE SHEATH AND 6F (PENUMBRA INC), NEUROFORM STENT SYSTEMS (BOSTON SCIENTIFIC). THIS COMPLAINT WILL CAPTURE ALL ADVERSE EVENTS POTENTIALLY ASSOCIATED WITH CNV DEVICES. ANY ADVERSE EVENTS ASSOCIATED WITH COMPETITORS OR UNKNOWN PRODUCTS OR ATTRIBUTED TO THE PATIENT¿S PREEXISTING CONDITIONS WILL BE EXCLUDED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS ASSOCIATED WITH CERENOVUS DEVICES: A 61-YEAR-OLD FEMALE PATIENT PRESENTED WITH RIGHT MIDDLE CEREBRAL ARTERY (MCA) EMBOLUS, RECANALIZED WITH INTRA-ARTERIAL ABCIXIMAB WITH GOOD ANGIOGRAPHIC RESULTS. A 44-YEAR-OLD MALE PATIENT PRESENTED WITH RIGHT THALAMIC THROMBOEMBOLISM AND INFARCTION. A 74-YEAR-OLD FEMALE PATIENT PRESENTED WITH AN EMBOLIC STROKE DURING THE FIRST PROCEDURE. THE EVENT WAS TREATED WITH INTERNUCLEAR OPHTHALMOPLEGIA (INO). THE EVENT WAS RESOLVED COMPLETELY OVER 6 MONTHS. IN ADDITION DURING THE PROCEDURE, THE STENT WAS DISPLACED. A 46-YEAR-OLD FEMALE PATIENT EXPERIENCED AN ASYMPTOMATIC RIGHT POSTERIOR CEREBRAL ARTERY (PCA) OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510483 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening 6F GUIDE SHEATH AND 6F (PENUMBRA INC)| NEUROFORM STENT SYSTEMS (BOSTON SCIENTIFIC)| NEURON DELIV CATH 6F GIDE CATH (PENUMBRA INC)