BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 23351167 · Received October 21, 2025

    Report

    Report Number
    2029214-2025-02252
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    May 1, 2025
    Report Date
    January 7, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID NV UNK PIPELINE (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A CITATION: PANDO, A., HA, C. J., THIBAULT, D., KHANDELWAL, P., NAIR, A., SINGLA, A., <(>&<)> SUN, H.. FLOW DIVERTER ASSISTED EMBOLIZATION OF RUPTURED ANEURYSMS IS ASSOCIATED WITH INCREASED HEMORRHAGIC COMPLICATIONS: PROGNOSTIC FACTORS AND OUTCOMES IN NEUROENDOVASCULAR TREATMENT OF SUBARACHNOID HEMORRH. WORLD NEUROSURGERY 199 2025. DOI:10.1016/J.WNEU.2025.124061 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    THIS EVENT IS NO LONGER A REPORTABLE EVENT. MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL MDRS ARE REQUIRED. REVIEW OF THE ARTICLE AND COMPLAINT RECORD FINDS THIS INFORMATION WAS A DUPLICATE OF PREVIOUSLY REPORTED INFORMATION. THEREFORE ANY FURTHER INFORMATION REGARDING THIS EVENT WILL BE REPORTED IN THE REPORTS NOTED IN FIELD H10. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC LITERATURE REVIEW FOUND REPORTED OF DEATH, EMBOLIC STROKE, GASTROINTESTINAL BLEED, RESPIRATORY TRACT BLEEDING, HYDROCEPHALUS, REQUIRING EXTERNAL VENTRICULAR DRAIN/ VENTRICULOPERITONEAL SHUNT PLACEMENT, BLOOD TRANSFUSION, AND VASOSPASM IN ASSOCIATION WITH PIPELINE EMBOLIZATION DEVICE EMBOLIZATION. THE TIME FRAME OF THIS STUDY WAS FROM 2016 TO 2021. THE PURPOSE OF THIS ARTICLE WAS TO IDENTIFY FACTORS INFLUENCING TREATMENT SELECTION AND RISKS ASSOCIATED WITH PED VERSUS COIL EMBOLIZATION IN NONTRAUMATIC SUBARACHNOID HEMORRHAGES. THE AUTHORS REVIEWED 7,243 CASES OF PATIENTS TREATED FOR NONTRAUMATIC SUBARACHNOID HEMORRHAGE (RUPTURED ANEURYSMS). OF THE 7,243 PATIENTS, 6834 PATIENTS UNDERWENT ENDOVASCULAR COIL EMBOLIZATION AND 409 PATIENTS UNDERWENT PIPELINE EMBOLIZATION DEVICE/ FLOW DIVERSION. OF THE 409 PATIENTS IN THE PED GROUP, THE AVERAGE AGE WAS 56 YEARS, 279 WERE FEMALE AND 130 WERE MALE. OF THE 6834 PATIENTS IN THE COIL EMBOLIZATION GROUP, THE AVERAGE AGE WAS 57 YEARS, 4725 WERE FEMALE AND 2109 WERE MALE. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE PIPELINE. IN ADDITION, PATIENTS WHO UNDERWENT PED/FLOW DIVERTER PL ACEMENT WERE MORE THAN TWICE AS LIKELY TO EXPERIENCE BOTH INPATIENT GASTROINTESTINAL BLEEDING AND MORE THAN 4 TIMES AS LIKELY TO EXPERIENCE RESPIRATORY TRACT BLEEDING COMPARED TO PATIENTS TREATED WITH COIL EMBOLIZATION. THE HIGHER INCIDENCE OF GASTROINTESTINAL BLEEDING IN THOSE WITH PED/FLOW DIVERTER PLACEMENT IS LIKELY DUE TO THE ROUTINE USE OF ANTIPLATELET THERAPY IN PATIENTS WHO RECEIVE PED/FLOW DIVERTER PLACEMENT. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: 43 PATIENTS DIED IN THE PED GROUP AND 941 PATIENTS DIED IN THE COIL EMBOLIZATION GROUP EMBOLIC STROKE OCCURRED IN 10 PATIENTS IN THE PED GROUP AND 138 PATIENTS IN THE COIL EMBOLIZATION GROUP GASTROINTESTINAL BLEEDING OCCURRED IN 21 PATIENTS IN THE PED GROUP AND 149 PATIENTS IN THE COIL EMBOLIZATION GROUP RESPIRATORY TRACT BLEEDING OCCURRED IN 13 PATIENTS IN THE PED GROUP AND 45 PATIENTS IN THE COIL EMBOLIZATION GROUP HYDROCEPHALUS OCCURRED IN 194 PATIENTS IN THE PED GROUP AND 3870 PATIENTS IN THE COIL EMBOLIZATION GROUP EXTERNAL VENTRICULAR DRAIN (EVD)/ VENTRICULOPERITONEAL SHUNT (VP SHUNT) PLACEMENT WAS REQUIRED IN 159 PATIENTS IN THE PED GROUP AND 3308 PATIENTS IN THE COIL EMBOLIZATION GROUP BLOOD TRANSFUSION REQUIRED IN 24 PATIENTS IN THE PED GROUP AND 338 PATIENTS IN COIL EMBOLIZATION GROUP VASOSPASM OCCURRED IN 139 PATIENTS IN THE PED GROUP AND 2389 PATIENTS IN THE COIL EMBOLIZATION GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236361 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O SEE H11...