BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKPROWLER

    MDR report key: 12574111 · Received October 5, 2021

    Report

    Report Number
    3008114965-2021-00496
    Event Type
    Injury
    Date Received
    October 5, 2021
    Date of Event
    September 3, 2014
    Report Date
    September 9, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRA
    PMA / PMN Number
    K003925
    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: ¿DIABETES MELLITUS DOES NOT INCREASE THE RISK OF ADVERSE LONG-TERM OUTCOMES AFTER INTRACRANIAL STENT PLACEMENT¿ REVIEWED. LI BH, YIN YW, GAO CY, HU ZC, WANG JH, ZHANG LL, LI JC. CELL BIOCHEM BIOPHYS. 2015 JAN;71(1):413-8. DOI: 10.1007/S12013-014-0214-Z. PMID: 25182003. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    LITERATURE ARTICLE ¿DIABETES MELLITUS DOES NOT INCREASE THE RISK OF ADVERSE LONG-TERM OUTCOMES AFTER INTRACRANIAL STENT PLACEMENT¿ REVIEWED. LI BH, YIN YW, GAO CY, HU ZC, WANG JH, ZHANG LL, LI JC. CELL BIOCHEM BIOPHYS. 2015 JAN;71(1):413-8. DOI: 10.1007/S12013-014-0214-Z. PMID: 25182003. OBJECTIVE AND METHODS: ¿THE PRESENT STUDY IS TO INVESTIGATE WHETHER DIABETES MELLITUS (DM) INCREASES RISK OF ADVERSE LONG-TERM OUTCOMES AFTER INTRACRANIAL STENT PLACEMENT. PATIENTS RECEIVING INTRACRANIAL STENTING WERE ASSIGNED TO DM GROUP AND NON-DM GROUP ACCORDING TO DIABETES STATUS.¿ ¿A TOTAL OF 44 STENOSES IN 43 PATIENTS WERE RETROSPECTIVELY ANALYZED.¿ ¿AFTER ADJUSTING FOR THE CONFOUNDERS, THE RISK OF DM VERSUS NON-DM FOR COMPOSITE OUTCOMES REMAINED INSIGNIFICANT.¿ ¿THERE IS NO EVIDENCE THAT DM INCREASES THE RISK OF ADVERSE LONG-TERM OUTCOMES AFTER INTRACRANIAL STENT PLACEMENT¿. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: PROWLER14 MICROCATHETER CORDIS, 6F-GUIDING CATHETER ENVOY CORDIS. OTHER CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: 0.01400 MICRO-GUIDE WIRE, WIZDOM, 0.01400 MICRO-GUIDE WIRE, TRANSCEND-14, BALLOON CATHETERS RYUJINPLUS, TERUM, BALLOON-EXPANDABLE STENTS, APOLLO, MICROPORT, GUIDANT MIMI VISION, GUIDANT, CLEARFLEX, CLENRSTREAM. INVASTENT, VOLO. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: INTRACRANIAL HEMORRHAGE, HYPERFUSION POSTOPERATION, VESSEL PERFORATION INTRA-OP, SPECIFIC INTERVENTIONS WERE NOT PROVIDED PER ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474807 UNKPROWLER MICROCATHETER KRA MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening 0.01400 MICRO-GUIDE WIRE, TRANSCEND-14| 0.01400 MICRO-GUIDE WIRE, WIZDOM| BALLOON CATHETERS RYUJINPLUS, TERUM| BALLOON-EXPANDABLE STENTS, APOLLO, MICROPORT| CLEARFLEX, CLENRSTREAM| GUIDANT MIMI VISION, GUIDANT| INVASTENT, VOLO