BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 15573489 · Received October 10, 2022

    Report

    Report Number
    3008114965-2022-00650
    Event Type
    Injury
    Date Received
    October 10, 2022
    Date of Event
    May 14, 2014
    Report Date
    October 10, 2022
    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

    PRODUCT COMPLAINT # (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: FANG YB, LI Q, WU YN, ZHANG Q, YANG PF, ZHAO WY, HUANG QH, HONG B, XU Y, LIU JM. OVERLAPPING STENTS FOR BLOOD BLISTER-LIKE ANEURYSMS OF THE INTERNAL CAROTID ARTERY. CLIN NEUROL NEUROSURG. 2014 AUG;123:34-9. DOI: 10.1016/J.CLINEURO.2014.04.023. EPUB 2014 MAY 14. PMID: 25012008. 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 CONTACT INFORMATION 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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. VASOSPASM IS LISTED AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE STENT. THERE WAS NO MENTION OF A DEVICE MALFUNCTION OR THAT THE EVENT IS RELATED TO A DEVICE DESIGN OR MANUFACTURING ISSUE. GIVEN THAT THE ENTERPRISE STENT WAS USED ON ALL THE PATIENTS WHO WERE MENTIONED TO EXPERIENCE VASOSPASM, THE RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE ENTERPRISE STENT CANNOT BE EXCLUDED. AND SINCE THIS EVENT REQUIRED A MEDICAL INTERVENTION ON ONE OF THE PATIENTS TO PRECLUDE PERMANENT IMPAIRMENT OR INJURY TO A PATIENT, THIS EVENT IS CONSIDERED AS SERIOUS AND MDR REPORTABLE. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: FANG YB, LI Q, WU YN, ZHANG Q, YANG PF, ZHAO WY, HUANG QH, HONG B, XU Y, LIU JM. OVERLAPPING STENTS FOR BLOOD BLISTER-LIKE ANEURYSMS OF THE INTERNAL CAROTID ARTERY. CLIN NEUROL NEUROSURG. 2014 AUG;123:34-9. DOI: 10.1016/J.CLINEURO.2014.04.023. EPUB 2014 MAY 14. PMID: 25012008. OBJECTIVE AND METHODS: THIS ARTICLE SOUGHT TO EVALUATE THE SAFETY AND EFFICACY OF STENT-ASSISTED COILING AND SUBSEQUENT OVERLAPPING STENTS (SAC + OS) IN THE TREATMENT OF BLOOD BLISTER-LIKE ANEURYSMS (BBAS, ANEURYSMS WITH FRAGILE NECK). THE RETROSPECTIVE STUDY ENROLLED FIFTEEN (15) PATIENTS WITH RUPTURED BBAS MANAGED SUCESSFULLY WITH SAC + OS (BETWEEN APR 2009 AND DEC 2013) WHOSE CLINICAL CHARACTERISTICS, PROCEDURAL DATA, ANGIOGRAPHIC OUTCOME AND FOLLOW UP RESULTS WERE REVIEWED. NONE OF THE PATIENTS HAS IMPORTANT COMORBIDITIES OR RISK FACTORS FOR BLEEDING, AND THE PREVIOUS MRS SCORE OF EVERY PATIENT IS ZERO. ENDOVASCULAR TREATMENT WERE PERFORMED UNDER GENERAL ANESTHESIA AS EARLY AS POSSIBLE AFTER DIAGNOSIS. CLOSE-CELL DESIGNED SELF-EXPANDING NEUROVASCULAR STENTS (ENTERPRISE, SOLITAIRE, OR LEO) WAS/WERE PREFERRED FOR RECONSTRUCTION OF THE PARENT ARTERY BASED ON THE OPERATOR'S EXPERIENCE AND THE HEMODYNAMIC MODIFICATION STATUS AFTER DEPLOYMENT OF THE FIRST STENT. SAC WAS APPLIED VIA MODIFIED JAILING TECHNIQUE. ALL PATIENTS RECEIVED SYSTEMIC IV HEPARIN AT THE START OF THE PROCEDURE AND CONTINUED ON ANTIPLATELET THERAPY INDEFINITELY. FOLLOW-UP ANGIOGRAPHY WAS PERFORMED WITHIN 2 WEEKS AND AT 3 MONTHS AFTER EMBOLIZATION. MAGNETIC RESONANCE ANGIOGRAPHY WAS RECOMMENDED AT 6 MOS AND 1 YEAR AFTER TREATMENT. CLINICAL OUTCOMES WERE ASSESSED USING THE MODIFIED RANKIN SCALE (MRS) VIA NEURO EXAMINATION/TELEPHONE INTERVIEW. OUT OF THE 15 CASES, 9 HAD DOUBLE STENTS, 5 HAD TRIPLE STENTS, AND 1 HAD QUADRUPLE STENTS. OTHER THEN CEREBRAL VASOSPASM, THERE WERE NO OTHER PROCEDURE RELATED COMPLICATIONS THAT WERE DETECTED. THE PATIENTS WHO EXPERIENCED VASOSPASM WERE LISTED TO HAVE RECEIVED THE ENTERPRISE STENTS (2,3,4) ONLY. WITHIN THE 2 WEEKS FOLLOW-UP PERIOD, ALL THOSE TREATED WITH TRIPLE AND QUADRUPLE STENTS HAD TOTALLY OCCLUDED ANEURYSMS ANGIOGRAPHICALLY; WHILE THERE WERE 3 PATIENT WHO WERE TREATED WITH DOUBLE STENTS THAT HAD MAJOR RECURRENCE WITHOUT REBLEEDING AND WERE RETREATED ENDOVASCULARLY (2 BY SAD, 1 BY STENTING AND ONYX). THESE 3 PATIENTS RECEIVED THE NON-CERENOVUS STENTS. THERE WAS NO MENTION IN THE ARTICLE REGARDING WHAT SPECIFIC COILS EACH PATIENT RECEIVED. 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: NONE MENTIONED NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: SOLITAIRE STENT, LEO STENT, HYDROSOFT COILS, HYPERSOFT COILS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 4 = CEREBRAL VASOSPASM. 3 PATIENTS HAD SYMPTOMS (NO SPECIFIC SYMPTOM MENTIONED) AND 1 OF THEM WAS MENTIONED TO HAVE SEVERE SPASM AT THE 6TH POSTOPERATIVE DAY. 1 PATIENT HAD AN ENDOVASCULAR FASUDIL INFUSION. NO TREATMENT/ INTERVENTION WAS MENTIONED FOR THE REMAINING PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2800431 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening HYDROSOFT COILS| HYPERSOFT COILS| LEO STENT| SOLITAIRE STENT