BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 12599530 · Received October 8, 2021

    Report

    Report Number
    1226348-2021-00091
    Event Type
    Injury
    Date Received
    October 8, 2021
    Date of Event
    September 14, 2014
    Report Date
    September 12, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: WON YS, RHO MH, CHUNG EC, HONG HP, KIM SY, PARK HJ, CHOI YJ, LEE SY, CHOI CS, IHN YK. MULTIPLE OVERLAPPING STENT-ASSISTED COILING OF COMPLEX ANEURYSMS: A SINGLE-CENTER EXPERIENCE. NEUROL RES. 2015 MAR;37(3):189-96. DOI: 10.1179/1743132814Y.0000000444. EPUB 2014 SEP 12. ERRATUM IN: NEUROL RES. 2015 APR;37(4):375. YON, YU SAM [CORRECTED TO WON, YU SAM]. PMID: 25213599. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: WON YS, RHO MH, CHUNG EC, HONG HP, KIM SY, PARK HJ, CHOI YJ, LEE SY, CHOI CS, IHN YK. MULTIPLE OVERLAPPING STENT-ASSISTED COILING OF COMPLEX ANEURYSMS: A SINGLE-CENTER EXPERIENCE. NEUROL RES. 2015 MAR;37(3):189-96. DOI: 10.1179/1743132814Y.0000000444. EPUB 2014 SEP 12. ERRATUM IN: NEUROL RES. 2015 APR;37(4):375. YON, YU SAM [CORRECTED TO WON, YU SAM]. PMID: 25213599. OBJECTIVE AND METHODS: THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE FEASIBILITY AND MID-TERM OUTCOMES OF COMPLEX ANEURYSMS AFTER MULTIPLE OVERLAPPING STENT ASSISTED COILING (OSAC). RETROSPECTIVELY EVALUATED 26 WIDE-NECKED AND FUSIFORM ATHEROSCLEROTIC OR DISSECTING ANEURYSMS (CAPTURED IN TABLE 1) THAT WERE TREATED WITH MULTIPLE OSAC. EIGHT ANEURYSMS (30.8%) PRESENTED WITH SUBARACHNOID HEMORRHAGE AND ONE (3.9%) WITH INTRACRANIAL HEMORRHAGE. THE ARTICLE REPORTS PROCEDURES UTILIZED CERENOVUS AND NON CERENOVUS PRODUCTS WITHIN THE STUDY GROUP AND ONLY IDENTIFIES WHICH MANUFACTURERS STENT(S) WERE UTILIZED IN EACH PATIENT. 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: 6F ENVOY GUIDING CATHETER NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: 6F SHUTTLE SHEATH (COOK), CLOSING DEVICE (ANGIOSEAL -ST JUDE MEDICAL), PERCLOSE (ABBOTT), NEUROFORM STENT (BOSTON SCIENTIFIC), SOLITAIRE STENT (EV3) COILS WERE UTILIZED BUT THE ARTICLE DOES NOT IDENTIFY MANUFACTURER OF COILS. ARTICLE ALSO DOES NOT IDENTIFY WHICH MANUFACTURER DEVICES ARE ASSOCIATED WITH THE ADVERSE EVENTS (BESIDES THE STENT). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS (CROSS REFERENCE OF TABLE 1 WITH NARRATIVE DESCRIPTIONS): PATIENT (B)(6) FEMALE WITH ICA UNRUPTURED ANEURYSM LOCATION IMPLANTED WITH ENTERPRISE STENT EXPERIENCED IN-STENT THROMBOSIS TREATED WITH TIROFIBAN INJECTION WITH RESOLUTION OF THROMBOSIS BUT DECREASED MENTAL STATUS OUTCOME.. PATIENT (B)(6) FEMALE WITH MCA UNRUPTURED ANEURYSM LOCATION IMPLANTED WITH ENTERPRISE STENT EXPERIENCED IN-STENT THROMBOSIS TREATED WITH TIROFIBAN INJECTION WITH TRANSIENT RIGHT SIDED WEAKNESS. PATIENT (B)(6) MALE WITH MCA UNRUPTURED ANEURYSM LOCATION IMPLANTED WITH ENTERPRISE STENT EXPERIENCED IN-STENT THROMBOSIS TREATED WITH TIROFIBAN INJECTION WITH NO INFORMATION ON OUTCOME. PATIENT (B)(6) MALE WITH MCA UNRUPTURED ANEURYSM LOCATION IMPLANTED WITH ENTERPRISE STENT EXPERIENCED IN-STENT THROMBOSIS TREATED WITH TIROFIBAN INJECTION WITH NO INFORMATION ON OUTCOME. PATIENT (B)(6) MALE WITH SCA UNRUPTURED ANEURYSM LOCATION IMPLANTED WITH ENTERPRISE STENT EXPERIENCED IN-STENT THROMBOSIS TREATED WITH TIROFIBAN INJECTION WITH OUTCOME OF APHASIA WITH QUADRIPLEGIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494902 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention 6F ENVOY GUIDING CATHETER| 6F SHUTTLE SHEATH (COOK)| CLOSING DEVICE (ANGIOSEAL -ST JUDE MEDICAL)| NEUROFORM STENT (BOSTON SCIENTIFIC)| PERCLOSE (ABBOTT)| SOLITAIRE STENT (EV3)