BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 21608272 · Received March 14, 2025

    Report

    Report Number
    2029214-2025-00679
    Event Type
    Injury
    Date Received
    March 14, 2025
    Report Date
    March 14, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: NV UNK PIPELINE (LOT: UNKNOWN); IMPLANT DATE: N/A; EXPLANT DATE: N/A. G2: CITATION: AUTHORS: NICKELSEN PM, NEYENS R, AL KASAB S.. CLOPIDOGREL HYPERRESPONSIVENESS AND HEMORRHAGIC COMPLICATIONS USING ON-LABEL CLOPIDOGREL DOSING AFTER PIPELINE EMBOLIZATION. JOURNAL OF PHARMACY PRACTICE 38(1) 99¿106 2025. DOI: 10.1177/08971900241273311. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF INTRACRANIAL HEMORRHAGE, INTERNAL CAROTID ARTERY PERFORATION, GROIN HEMATOMA, HEMATURIA, GASTROINTESTINAL BLEED, THROMBOTIC COMPLICATIONS, AND IN-STENT OCCLUSION IN ASSOCIATION WITH PIPELINE EMBOLIZATION. THE PURPOSE OF THIS ARTICLE WAS TO COMPARE HEMORRHAGIC COMPLICATIONS BETWEEN PATIENTS TAKING STANDARD DOSE CLOPIDOGREL WHOM ARE DEEMED CLOPIDOGREL HYPERRESPONSIVE TO THOSE WHO ARE DEEMED CLOPIDOGREL NORMORESPONSIVE FOLLOWING PED FLOW DIVERSION OF COMPLEX CEREBRAL ANEURYSMS. THE AUTHORS REVIEWED 148 CASES OF PATIENTS TREATED FOR ANEURYSMS USING CLOPIDOGREL POST PIPELINE EMBOLIZATION (54 PATIENTS WERE HYPERRESPONSIVE AND 94 PATIENTS WERE NORMORESPONSIVE TO CLOPIDOGREL.) OF THE 148 PATIENTS, THE AVERAGE AGE WAS 56 YEARS, 116 WERE FEMALE AND 32 WERE MALE. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE PIPELINE DEVICE. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: INTRACRANIAL HEMORRHAGE INTRA-OP INTERNAL CAROTID ARTERY PERFORATION GROIN HEMATOMA HEMATURIA GASTROINTESTINAL BLEED THROMBOTIC COMPLICATIONS DURING OR IMMEDIATELY POST PROCEDURE IN-STENT PARTIAL OR COMPLETE OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546720 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other