BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDE CATHETER

    MDR report key: 12566285 · Received October 2, 2021

    Report

    Report Number
    3008264254-2021-00029
    Event Type
    Injury
    Date Received
    October 2, 2021
    Report Date
    September 7, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    DQY
    PMA / PMN Number
    K000715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). LITERATURE CITATION: GAO X, LIANG G, LI Z, WEI X, WANG X, ZHANG H, FENG S, LIN J. WINGSPAN STENT-ASSISTED COILING OF INTRACRANIAL ANEURYSMS WITH SYMPTOMATIC PARENT ARTERY STENOSIS: EXPERIENCE IN 35 PATIENTS WITH MID-TERM FOLLOW-UP RESULTS. EUR J RADIOL. 2012 MAY;81(5):E750-6. DOI: 10.1016/J.EJRAD.2012.01.036. EPUB 2012 FEB 29. PMID: 22381442. 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 · 1

    LITERATURE ARTICLE "WINGSPAN STENT-ASSISTED COILING OF INTRACRANIAL ANEURYSMS WITH SYMPTOMATIC PARENT ARTERY STENOSIS: EXPERIENCE IN 35 PATIENTS WITH MID-TERM FOLLOW-UP RESULTS" WAS REVIEWED. GAO X, LIANG G, LI Z, WEI X, WANG X, ZHANG H, FENG S, LIN J. EUR J RADIOL. 2012 MAY;81(5):E750-6. DOI: 10.1016/J.EJRAD.2012.01.036. EPUB 2012 FEB 29. PMID: 22381442. "OBJECTIVE AND METHODS: THERE IS A POTENTIAL RISK OF ANEURYSM RUPTURE AFTER PARENT ARTERY REVASCULARIZATION BECAUSE OF INCREASED BLOOD FLOW. THE PURPOSE OF THIS STUDY IS TO ASSESS THE EFFICACY AND SAFETY OF WINGSPAN STENT ASSISTED COIL EMBOLIZATION IN THE TREATMENT OF INTRACRANIAL ANEURYSMS WITH SYMPTOMATIC PARENT ARTERY STENOSIS. THIRTY-FIVE CONSECUTIVE PATIENTS (19 MEN, 16 WOMEN; AGE RANGE, 48¿79 YEARS; MEAN AGE, 60.4 YEARS) HARBORING 35 UNRUPTURED WIDE-NECKED OR FUSIFORM INTRACRANIAL ANEURYSMS (MEAN SIZE 6.8 MM; RANGE 2.5¿18 MM.) WITH SYMPTOMATIC PARENT ARTERY STENOSIS (MEAN DEGREE 71.1%; RANGE 50¿92%) WERE TREATED WITH THE WINGSPAN STENT-ASSISTED COILING. TWENTY-FOUR LESIONS WERE LOCATED IN THE ANTERIOR CIRCULATION AND ELEVEN IN THE POSTERIOR CIRCULATION. PATIENTS WERE PREMEDICATED WITH ANTIPLATELET THERAPY CONSISTING OF ASPIRIN 300 MG AND CLOPIDOGREL 75 MG FOR AT LEAST 3 DAYS BEFORE THE PROCEDURE. FOLLOWING PRE-DILATATION AND STENT PLACEMENT, A COILING MICROCATHETER ENTERED THE ANEURYSM THROUGH THE INTERSTICES OF THE STENT, AND THEN COILING WAS PERFORMED. AFTER THE PROCEDURE, CLOPIDOGREL 75 MG DAILY WAS RECOMMENDED FOR AN ADDITIONAL 30 DAYS, AND ASPIRIN 100 MG WAS RECOMMENDED THROUGHOUT FOLLOW-UP. FOR ALL PATIENTS, CLINICAL FOLLOW-UP WAS CONDUCTED BY CLINIC VISITATION, OR TELEPHONE INTERVIEW. ANGIOGRAPHIC FOLLOW-UP WITH DSA WAS RECOMMENDED AT 6 MONTHS AND 1 YEAR AFTER THE PROCEDURE. ANGIOGRAPHY FOLLOW-UP (MEAN TIME 10.6 MONTHS) WAS OBTAINED IN 31 CASES (88.6%). THE TECHNICAL FEASIBILITY OF THE PROCEDURE, PROCEDURE-RELATED COMPLICATIONS, ANGIOGRAPHIC RESULTS, CLINICAL OUTCOME AND FOLLOW-UP ANGIOGRAPHY WERE EVALUATED. IN EVERY CASE, TECHNICAL SUCCESS WAS ACHIEVED. THE DEGREE OF STENOSIS WAS REDUCED FROM 71.1% TO 17.4% AFTER BALLOON ANGIOPLASTY AND STENTING. IMMEDIATE ANGIOGRAPHY DEMONSTRATED COMPLETE OCCLUSION IN 25 CASES (71.4%), NECK REMNANT IN 7 CASES (20.0%), AND INCOMPLETE OCCLUSION IN 3 CASES (8.6%). PROCEDURE-RELATED MORBIDITY OCCURRED IN TWO PATIENTS (5.7%), INCLUDING THROMBOEMBOLISM (N = 1) AND OCCLUSION OF SMALL PENETRATING ARTERIES (N = 1). AT FOLLOW-UP (MEAN TIME 18.3 MONTHS), TWO ADDITIONAL CASES OF ISCHEMIC STROKE OCCURRED. THE OVERALL FREQUENCY OF ANY STROKE, INTRACRANIAL HEMORRHAGE, OR DEATH WITHIN 30 DAYS OR IPSILATERAL STROKE BEYOND 30 DAYS WAS 11.4%. NO REHEMORRHAGE OF TREATED ANEURYSM OCCURRED. AT ANGIOGRAPHIC FOLLOW-UP, FOUR CASES DEMONSTRATED =50% IN-STENT RESTENOSIS (12.9%), ONE OF WHICH WAS SYMPTOMATIC, AND TWO ANEURYSMS (6.4% OF THE FOLLOW-UP ANGIOGRAMS) DEMONSTRATED RECANALIZATION. CONCLUSION: WE FOUND THAT THE WINGSPAN STENT-ASSISTED COIL EMBOLIZATION WAS HELPFUL IN THE TREATMENT OF INTRACRANIAL ANEURYSMS WITH PARENT ARTERY STENOSIS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNIFEMORAL GUIDING CATHETER (JOHNSON & JOHNSON), 6F OR 8F ENVOY GUIDING CATHETER (JOHNSON & JOHNSON). OTHER CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: TRANSEND SOFT TIP OR TRANSEND FLOPPY, BOSTON SCIENTIFIC, BOSTON, MA, USA. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: CASE 3 - 59/M STENT THROMBISIS, CASE 11 - 68/F STROKE WITHIN 24HRS, CASE 24 - 61/F VASOSPASM"..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463960 GUIDE CATHETER PERCUTANEOUS CATHETER DQY MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other