BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKENTERPRISE2

    MDR report key: 19463884 · Received June 4, 2024

    Report

    Report Number
    3008114965-2024-00575
    Event Type
    Injury
    Date Received
    June 4, 2024
    Date of Event
    April 1, 2024
    Report Date
    June 11, 2024
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 11-JUN-2024. [ADDITIONAL INFORMATION]: ON 11-JUN-2024, CONFIRMATION FROM THE AUTHOR WAS RECEIVED. PER THE INFORMATION, THERE WAS NO RELEVANCE BETWEEN THE HARM AND THE JNJ PRODUCT IN THE ARTICLE. HOWEVER, THE ARTICLE CLEARLY INDICATES THE IN-STENT THROMBOSIS (QTY 1) AND IN-STENT RESTENOSIS (QTY 12) OCCURRED WITH THE ENTERPRISE STENTS. IN STENT STENOSIS WITH A CNV DEVICE IS A REPORTABLE EVENT IF THE INCIDENT OCCURRED WITHIN ONE YEAR OF THE STENT IMPLANTATION. PER THE ARTICLE, THE FOLLOW-UP PERIOD WAS 3-12 MONTHS; THEREFORE, THE EVENTS OF THE IN-STENT THROMBOSIS (QTY 1) AND IN-STENT RESTENOSIS (QTY 12) ARE REPORTABLE TO THE US FDA. THE EVENTS OF ¿BRANCH EMBOLIZATION, SYMPTOMATIC HEMORRHAGE, AND VASOSPASM,¿ IS NO LONGER BEING REPORTED TO THE US FDA, SINCE THE AUTHOR HAS CONFIRMED THE EVENTS WERE NOT ATTRIBUTED TO THE STENT. THERE MAY BE CLINICAL AND PROCEDURAL FACTORS, INCLUDING VESSEL CHARACTERISTICS, TORTUOSITY, DEVICE SELECTION, AND MECHANICAL MANIPULATION OF DEVICES WITHIN THE ARTERY, THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. BASED ON THE ASSESSMENT OF THE STUDY¿S AUTHOR, THE EVENTS NO LONGER MEETS US FDA REPORTING CRITERIA. UPDATED SECTIONS. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: MA L, ZHANG H, DUAN G, LUO Y, ZHANG X, LU Z, CHEN Z, YU L, ZHANG T, XU Y, LI J. ENTERPRISE STENTS FOR THE TREATMENT OF SYMPTOMATIC NON-ACUTE INTRACRANIAL ARTERY STENOSIS DISEASE: SAFETY AND EFFICIENCY EVALUATION. NEUROL RES. 2024 JUN;46(6):538-543. DOI: 10.1080/01616412.2024.2337518. EPUB 2024 APR 1. PMID: 38561007. 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 H.4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. SINCE THE EVENTS ARE LIFE THREATENING AND MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR COULD REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS. THE EVENTS ARE REPORTABLE TO THE US FDA. THE COMPLAINT WILL BE UPDATED WITH ANY ADDITIONAL INFORMATION RECEIVED FROM PERFORMING FOLLOW-UP ACTIVITY WITH THE CORRESPONDING AUTHOR, AND REPORTABILITY FOR THE US FDA WILL BE REASSESSED. 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 AND THE FOLLOWING CITATION WAS REVIEWED: MA L, ZHANG H, DUAN G, LUO Y, ZHANG X, LU Z, CHEN Z, YU L, ZHANG T, XU Y, LI J. ENTERPRISE STENTS FOR THE TREATMENT OF SYMPTOMATIC NON-ACUTE INTRACRANIAL ARTERY STENOSIS DISEASE: SAFETY AND EFFICIENCY EVALUATION. NEUROL RES. 2024 JUN;46(6):538-543. DOI: 10.1080/01616412.2024.2337518. EPUB 2024 APR 1. PMID: 38561007. BACKGROUND AND PURPOSE: ENTERPRISE STENT WAS APPROVED FOR THE TREATMENT OF WIDE-NECKED INTRACRANIAL ANEURYSMS. HOWEVER, IT HAS BEEN WIDELY USED IN THE ENDOVASCULAR TREATMENT OF INTRACRANIAL ARTERY STENOSIS, WHICH IS STILL CONTROVERSIAL. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE SAFETY AND EFFICIENCY OF THE ENTERPRISE STENT IN THE ENDOVASCULAR TREATMENT OF INTRACRANIAL ARTERY STENOSIS DISEASE. CERENOVUS DEVICES THAT WERE USED IN THIS STUDY: QTY UNK: ENTERPRISE STENTS ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR ENTERPRISE STENTS: QTY 3: BRANCH EMBOLIZATION. TREATMENTS NOT DISCLOSED (EMBOLISM/RECOGNIZED PROCEDURAL COMPLICATION). QTY 1: IN-STENT THROMBOSIS. TREATMENT NOT DISCLOSED (THROMBOSIS/RECOGNIZED PROCEDURAL COMPLICATION). QTY 2: SYMPTOMATIC HEMORRHAGE, PROTAMINE WAS USED TO NEUTRALIZE THE HEPARIN (CEREBRAL HEMORRHAGE/MEDICATION REQUIRED). QTY 12: IN-STENT RESTENOSIS. TREATMENTS NOT DISCLOSED (ARTERIAL STENOSIS/RECOGNIZED PROCEDURAL COMPLICATION). QTY 4: VASOSPASM WHICH WAS RELIEVED WITH PAPAVERINE (ARTERIAL SPASM/MEDICATION REQUIRED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202960 UNKENTERPRISE2 INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening