BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 12573817 · Received October 4, 2021

    Report

    Report Number
    1226348-2021-00083
    Event Type
    Injury
    Date Received
    October 4, 2021
    Date of Event
    April 22, 2016
    Report Date
    September 9, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: QIN X, XU F, MAIMAITI Y, ZHENG Y, XU B, LENG B, CHEN G. ENDOVASCULAR TREATMENT OF POSTERIOR CEREBRAL ARTERY ANEURYSMS: A SINGLE CENTER'S EXPERIENCE OF 55 CASES. J NEUROSURG. 2017 APR;126(4):1094-1105. DOI: 10.3171/2016.1.JNS152447. EPUB 2016 APR 22. PMID: 27104845. 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. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: QIN X, XU F, MAIMAITI Y, ZHENG Y, XU B, LENG B, CHEN G. ENDOVASCULAR TREATMENT OF POSTERIOR CEREBRAL ARTERY ANEURYSMS: A SINGLE CENTER'S EXPERIENCE OF 55 CASES. J NEUROSURG. 2017 APR;126(4):1094-1105. DOI: 10.3171/2016.1.JNS152447. EPUB 2016 APR 22. PMID: 27104845. OBJECTIVE AND METHODS: ANEURYSMS OF THE POSTERIOR CEREBRAL ARTERY (PCA) ARE UNCOMMON. THE AUTHORS' AIM IN THIS STUDY IS TO REPORT THEIR EXPERIENCE WITH THE ENDOVASCULAR TREATMENT OF PCA ANEURYSMS. BETWEEN JANUARY 2007 AND DECEMBER 2014, 55 PATIENTS WITH 59 PCA ANEURYSMS WERE TREATED USING THE ENDOVASCULAR APPROACH AT THE AUTHORS' INSTITUTION. THERE WERE 32 MEN AND 23 WOMEN, RANGING IN AGE FROM 9 TO 73 YEARS (MEAN 47.5 YEARS). TWENTY-THREE PATIENTS HAD 25 SACCULAR ANEURYSMS, AND 32 PATIENTS HAD 34 FUSIFORM/DISSECTING ANEURYSMS. THE ENDOVASCULAR MODALITIES INCLUDED THE FOLLOWING: 1) SELECTIVE OCCLUSION OF THE ANEURYSM (N = 22); 2) COMPLETE OCCLUSION OF THE ANEURYSM AND THE PARENT ARTERY (N = 20); 3) PARENT ARTERY OCCLUSION (N = 6); 4) PARTIAL COILING OF THE ANEURYSM AND THE PARENT ARTERY (N = 5); AND 5) OCCLUSION OF THE DISSECTING ANEURYSM SAC (N = 2). IN 20 OF THE 23 PATIENTS WITH SACCULAR ANEURYSMS, THE ANEURYSM WAS SELECTIVELY OCCLUDED WITH PRESERVATION OF THE PARENT ARTERY USING COILS ALONE OR IN COMBINATION WITH STENTS. IN 18 OF THE 32 PATIENTS WITH FUSIFORM/DISSECTING ANEURYSMS, THE ANEURYSM AND THE PARENT ARTERY WERE COMPLETELY OCCLUDED TOGETHER. NONE OF THE RUPTURED ANEURYSMS WERE TREATED WITH STENT-ASSISTED COILING. THE AUTHORS DO NOT PROVIDE INFORMATION TO IDENTIFY THE DEVICES USED TO TREAT EACH PATIENT. THE ADVERSE EVENTS CAPTURED IN THIS COMPLAINT ARE THE EVENTS THAT COULD BE ASSOCIATED WITH THE TWO CERENOVUS DEVICES UTILIZED IN SOME PATIENTS IN THIS STUDY: THE ENVOY GUIDE CATHETER AND/OR ENTERPRISE STENT. THE EVENTS THAT ARE ASSOCIATED WITH COMPETITOR DEVICES OR PATIENT¿S PREEXISTING CONDITION ARE EXCLUDED FROM THIS COMPLAINT. THE ACTUAL NUMBER OF CERENOVUS DEVICES ASSOCIATED WITH THE FOLLOWING ADVERSE EVENTS IS UNKNOWN. 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: ENVOY 6FR R 5 FR GUIDE CATHETER NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: ECHELON 14 MICROCATHETER (COVIDIEN) DETACHABLE COILS: GUGLIELMI (STRYKER), MICROPLEX (MICROVENTION), NXT FIBER (COVIDIEN) SOLITAIRE AB STENTS (EV3) ONYX EMBOLIC LIQUID. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS ASSOCIATED WITH CERENOVUS DEVICES: PT (B)(6): MALE (B)(6) PRESENTING WITH DIZZINESS SECONDARY TO A LARGE LEFT P2 DISSECTING PCA ANEURYSM WAS TREATED WITH ANEURYSM AND PA OCCLUSION. PATIENT EXPERIENCED A POSTOPERATIVE THALAMUS INFARCT. NO TREATMENT WAS SPECIFIED. PT (B)(6): MALE (B)(6) PRESENTING WITH IVH SECONDARY TO A LARGE LEFT P2 DISSECTING PCA ANEURYSM WAS TREATED WITH ANEURYSM AND PA OCCLUSION. PATIENT EXPERIENCED A POSTOPERATIVE OCCIPITAL LOBE AND THALAMUS INFARCT WITH ASSOCIATED HEMIANOPIA. NO TREATMENT WAS SPECIFIED. PT (B)(6): FEMALE (B)(6) PRESENTING WITH MASS EFFECT SECONDARY TO A LARGE RIGHT P2 FUSIFORM PCA ANEURYSM WAS TREATED WITH PA OCCLUSION. PATIENT EXPERIENCED A POSTOPERATIVE THALAMUS AND BASAL GANGLION INFARCT WITH ASSOCIATED HEMIPARESIS. NO TREATMENT WAS SPECIFIED. 1 UNSPECIFIED PATIENT WITH RECANALIZATION OF THE ANEURYSM IDENTIFIED ON ANGIOGRAM. TREATED WITH REPEAT EMBOLIZATION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471474 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DETACHABLE COILS: GUGLIELMI (STRYKER)| DETACHABLE COILS: MICROPLEX (MICROVENTION)| DETACHABLE COILS: NXT FIBER (COVIDIEN)| ECHELON 14 MICROCATHETER (COVIDIEN)| ENVOY 6FR R 5 FR GUIDE CATHETER| ONYX EMBOLIC LIQUID| SOLITAIRE AB STENTS (EV3)