BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKENTERPRISE2

    MDR report key: 19455938 · Received June 3, 2024

    Report

    Report Number
    3008114965-2024-00571
    Event Type
    Injury
    Date Received
    June 3, 2024
    Date of Event
    March 14, 2023
    Report Date
    June 13, 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 IS TO INCLUDE THE ADDITIONAL INFORMATION RECEIVED ON 12-JUN-2024, THAT CHANGED THE REPORTABILITY OF THE EVENT AS RELATED TO THIS PRODUCT REPORTED IN THIS MEDWATCH REPORT. [ADDITIONAL INFORMATION]: ON 12-JUN-2024, ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR. PER THE INFORMATION, THERE WAS NO RELEVANCE BETWEEN THE HARM AND THE JNJ PRODUCT IN THE ARTICLE. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: WU ZP, YIN JL, LIU SK, JI S, LIU JY, WANG HL, ZHANG YS, ZHANG DZ. ENTERPRISE STENTS VERSUS LOW-PROFILE VISUALIZED INTRALUMINAL SUPPORT STENTS FOR STENT-ASSISTED COILING OF UNRUPTURED PARACLINOID ANEURYSMS. TECHNOL HEALTH CARE. 2023;31(5):1855-1865. DOI: 10.3233/THC-220697. PMID: 37125582. 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, THEY ARE 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: WU ZP, YIN JL, LIU SK, JI S, LIU JY, WANG HL, ZHANG YS, ZHANG DZ. ENTERPRISE STENTS VERSUS LOW-PROFILE VISUALIZED INTRALUMINAL SUPPORT STENTS FOR STENT-ASSISTED COILING OF UNRUPTURED PARACLINOID ANEURYSMS. TECHNOL HEALTH CARE. 2023;31(5):1855-1865. DOI: 10.3233/THC-220697. PMID: 37125582. BACKGROUND AND PURPOSE: THIS STUDY COMPARED THE CLINICAL AND ANGIOGRAPHIC OUTCOMES OF UNRUPTURED PARACLINOID ANEURYSMS TREATED WITH ENTERPRISE (EP) STENTS AND LOW-PROFILE VISUALIZED INTRALUMINAL SUPPORT (LVIS) STENTS. A RETROSPECTIVE ANALYSIS OF THE CLINICAL AND RADIOLOGICAL DATA FROM 133 PATIENTS WITH 139 UNRUPTURED PARACLINOID ANEURYSMS, WHO RECEIVED AN EP OR AN LVIS STENT BETWEEN JANUARY 2017 AND JUNE 2021 AT TAIZHOU PEOPLE'S HOSPITAL, WAS PERFORMED. IMMEDIATE POSTOPERATIVE AND FOLLOW-UP ANGIOGRAPHIC RESULTS WERE ANALYZED RETROSPECTIVELY USING THE RAYMOND-ROY OCCLUSION CLASSIFICATION (RROC). ANY COMPLICATIONS FOLLOWING THE PROCEDURE AND THE PATIENTS' CLINICAL OUTCOMES WERE NOTED. CERENOVUS DEVICES THAT WERE USED IN THIS STUDY: QTY UNK: ENTERPRISE STENTS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR ENTERPRISE STENTS: PATIENT # 4 (53/F) : COIL PROLAPSE, TREATED WITH RESCUE STENT (DEVICE INEFFECTIVE/SURGICAL INTERVENTION). PATIENT # 5 (51/F) : STROKE, TREATED WITH TIROFIBAN (ISCHEMIC STROKE/MEDICATION REQUIRED). PATIENT # 6 (62/F) : STROKE, TREATED WITH TIROFIBAN (ISCHEMIC STROKE/MEDICATION REQUIRED). PATIENT # 7 (53/F): STROKE, TREATED WITH TIROFIBAN (ISCHEMIC STROKE/MEDICATION REQUIRED). PATIENT # 9 (61/M) : STROKE, TREATED WITH TIROFIBAN (ISCHEMIC STROKE/MEDICATION REQUIRED). PATIENT # 11 (46/F): PARENT ARTERY OCCLUSION, MANAGED WITH OBSERVATION AND LONG-TERM MONO-ANTIPLATELET THERAPY (THROMBOSIS/MEDICATION REQUIRED). PATIENT # 12 (53/F): PARENT ARTERY OCCLUSION, MANAGED WITH OBSERVATION AND LONG-TERM MONO-ANTIPLATELET THERAPY (THROMBOSIS/MEDICATION REQUIRED). ALL PATIENTS HAD AN OUTCOME OF MRS SCORE 0 -NO SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658604 UNKENTERPRISE2 INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening