BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 13020411 · Received December 16, 2021

    Report

    Report Number
    3008114965-2021-00691
    Event Type
    Injury
    Date Received
    December 16, 2021
    Date of Event
    June 17, 2021
    Report Date
    December 16, 2021
    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. THE CITATION IS AS FOLLOWS: CUI R, YAN L, KANG K, YANG M, YU Y, MO D, GAO F, WANG Y, LOU X, MIAO Z, MA N. LONG-TERM OUTCOME OF ENTERPRISE STENTING FOR SYMPTOMATIC ICAS IN A HIGH-VOLUME STROKE CENTER. FRONT NEUROL. 2021 JUN 17;12:672662. DOI: 10.3389/FNEUR.2021.672662. PMID: 34220681; PMCID: PMC8248485. 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 PHONE 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. 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. THE CITATION IS AS FOLLOWS: CUI R, YAN L, KANG K, YANG M, YU Y, MO D, GAO F, WANG Y, LOU X, MIAO Z, MA N. LONG-TERM OUTCOME OF ENTERPRISE STENTING FOR SYMPTOMATIC ICAS IN A HIGH-VOLUME STROKE CENTER. FRONT NEUROL. 2021 JUN 17;12:672662. DOI: 10.3389/FNEUR.2021.672662. PMID: 34220681; PMCID: PMC8248485. OBJECTIVE AND METHODS: THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE LONG-TERM CLINICAL EFFICACY OF THE ENTERPRISE STENT USED FOR PATIENTS WITH SYMPTOMATIC INTRACRANIAL ATHEROSCLEROTIC STENOSIS (ICAS) DUE TO HYPOPERFUSION. FROM MAY 2015 TO AUGUST 2019, A TOTAL OF 214 PATIENTS WITH 223 SYMPTOMATIC ICAS WERE TREATED WITH THE ENTERPRISE. AMONG THEM, 130 PATIENTS WITH 130 LESIONS TREATED WITH ENTERPRISE STENT WERE INCLUDED EVENTUALLY. THE MEAN AGE OF PATIENTS WAS 59.2 ± 8.5 YEARS, AND 66.2% OF PATIENTS WERE MALE. THE SUCCESSFUL RECANALIZATION RATE WAS 100%. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ENTERPRISE STENT (INCLUDING ONE 4MM X 23MM ENTERPRISE & ONE 4.5MM X 14MM ENTERPRISE), OTHER CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: 5F OR 6F ENVOY GUIDING CATHETER & PROWLER SELECT PLUS MICROCATHETER, NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: GATEWAY BALLOON (STRYKER). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: PERI-PROCEDURAL COMPLICATIONS: FIVE PATIENTS EXPERIENCED COMPLICATIONS WITHIN 72 H AFTER THE PROCEDURE, INCLUDING ONE DEATH ATTRIBUTABLE TO HYPER-PERFUSION INTRACRANIAL HEMORRHAGE AFTER MIDDLE CEREBRAL ARTERY (MCA) STENTING, ONE PATIENT WITH MAJOR STROKE DUE TO A FRONTAL LOBE HEMORRHAGE WITH SUBARACHNOID HEMORRHAGE (SAH) AFTER MCA STENTING, TWO PATIENTS WITH MINOR ISCHEMIC STROKE DUE TO IN-STENT THROMBOSIS (ONE MCA STENTING AND THE OTHER VERTEBRAL ARTERY (VA) STENTING), AND ONE PATIENT WITH MINOR HEMORRHAGIC STROKE AFTER VA STENTING. LONG-TERM OUTCOMES: STROKE OR DEATH OCCURRED IN SIX PATIENTS, INCLUDING ONE DEATH, THREE MAJOR STROKES, AND TWO MINOR STROKES. TABLE 2 OF THE ARTICLE OUTLINES THE 6 PATIENTS WHO EXPERIENCED STROKE IN THE TERRITORY OF THE STENTED ARTERY AFTER 30 DAYS: PATIENT 1 - BASILAR ARTERY (BA); STROKE OCCURRED 9 MONTHS POST-PROCEDURE, ISR NOTED ON MAGNETIC RESONANCE ANGIOGRAPHY (MRA), OUTCOME WAS FATAL; PATIENT 2 - MCA; MAJOR STROKE OCCURRED 8 MONTHS POST-PROCEDURE, ISR NOTED ON CTA; PATIENT 3 - BA; MAJOR STROKE OCCURRED 16 MONTHS POST-PROCEDURE; NO ISR NOTED ON DSA; PATIENT 4 - MCA; MAJOR STROKE OCCURRED 12.5 MONTHS POST-PROCEDURE; ISR NOTED ON CTA; PATIENT 5 - MCA; MINOR STROKE OCCURRED 12 MONTHS POST-PROCEDURE; ISR NOTED ON DSA; PATIENT 6 - INTERNAL CAROTID ARTERY (ICA); MINOR STROKE OCCURRED 27 MONTHS POST-PROCEDURE; ISR NOTED ON DSA. IN-STENT RESTENOSIS (ISR) OR IN-STENT OCCLUSION (>70%) WITHIN 1 YEAR AFTER THE PROCEDURE WAS REACHED BY 17 OF 118 PATIENTS AT A MEAN TIME OF 8.6 ± 3.3 MONTHS AFTER THE PROCEDURE. IN TOTAL, 4 OF 17 ISRS WERE SYMPTOMATIC. FIGURE 1 OF THE ARTICLE SUMMARIZES TWO PATIENTS WITH ISR BY DIGITAL SUBTRACTION ANGIOGRAPHY (DSA). FOR PATIENTS EVALUATED WITH DSA, ISR WAS DEFINED AS A >70% NARROWING OF THE STENTED SEGMENT OR IMMEDIATELY ADJACENT (WITHIN 5 MM) TO THE IMPLANTED STENT. A PATIENT PRESENTED WITH RIGHT LIMB WEAKNESS AND NUMBNESS FOR 10 MONTHS DUE TO SEVERE STENOSIS (70%) AT THE M1 SEGMENT OF THE LEFT MCA. THE LESION WAS DILATED WITH A 2.25 × 9 MM GATEWAY BALLOON AND IMPLANTED A 4 × 23 MM ENTERPRISE STENT. POSTOPERATIVE DSA SHOWED THE DEGREE OF STENOSIS DECREASED TO 5%. DSA AFTER 17 MONTHS OF THE PROCEDURE SHOWED SIGNIFICANT ISR. ANOTHER PATIENT PRESENTED WITH BILATERAL LOWER LIMBS WEAKNESS AND DIPLOPIA FOR 2 MONTHS DUE TO HIGH-GRADE STENOSIS (80%) AT THE MIDDLE SEGMENT OF THE BA. THE LESION WAS DILATED WITH A 2 × 9 MM GATEWAY BALLOON AND IMPLANTED A 4.5 × 14 MM ENTERPRISE STENT. POSTOPERATIVE DSA SHOWED THE DEGREE OF STENOSIS DECREASED TO 35%. DSA AFTER 6.33 MONTHS OF THE PROCEDURE SHOWED SIGNIFICANT ISR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919752 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening 5F OR 6F ENVOY GUIDING CATHETER| GATEWAY BALLOON (STRYKER)| PROWLER SELECT PLUS MICROCATHETER