BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 24704481 · Received March 26, 2026

    Report

    Report Number
    2029214-2026-00527
    Event Type
    Death
    Date Received
    March 26, 2026
    Date of Event
    July 9, 2025
    Report Date
    March 26, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE SOURCE/CITATION: ABDELSALAM, A., SANIKOMMU, S., GUADA, L., RAMSAY, I. A., SHRIGIRI, S., SILVA, M. A., LU, V. M., CHRISTOPHER, K. M., SWEID, A., WEINBERG, J. H., WU, E. M., ROSENWASSER, R. H., TJOUMAKARIS, S. I., ABECASSIS, I. J., HASSAN, A. E., JABBOUR, P. M., STARKE, R. M. (2025). THE BALLAST RADIAL ACCESS SYSTEM IN NEUROENDOVASCULAR PROCEDURES: A MULTICENTER INVESTIGATION OF 138 PATIENTS. JOURNAL OF CLINICAL NEUROSCIENCE, 139. HTTPS://DOI.ORG/10.1016/J.JOCN.2025.111460 A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF ONLINE AVAILABILITY OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. G.4. PMA CODE MISSING AS DEVICE MODEL AND LOT IS UNKNOWN. 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

    ABDELSALAM, A., SANIKOMMU, S., GUADA, L., RAMSAY, I. A., SHRIGIRI, S., SILVA, M. A., LU, V. M., CHRISTOPHER, K. M., SWEID, A., WEINBERG, J. H., WU, E. M., ROSENWASSER, R. H., TJOUMAKARIS, S. I., ABECASSIS, I. J., HASSAN, A. E., JABBOUR, P. M., STARKE, R. M. (2025). THE BALLAST RADIAL ACCESS SYSTEM IN NEUROENDOVASCULAR PROCEDURES: A MULTICENTER INVESTIGATION OF 138 PATIENTS. JOURNAL OF CLINICAL NEUROSCIENCE, 139. HTTPS://DOI.ORG/10.1016/J.JOCN.2025.111460 LITERATURE WAS REVIEWED REGARDING THE SAFETY AND EFFECTIVENESS OF A TRANSRADIAL LARGE-BORE GUIDING CATHETER SYSTEM FOR NEUROVASCULAR INTERVENTIONS, INCLUDING STROKE AND ANEURYSM TREATMENT. MULTIPLE MANUFACTURERS¿ DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: PIPELINE FLEX EMBOLIZATION DEVICE, NAVIEN INTERMEDIATE CATHETER, AND PHENOM MICROCATHETER. ONE DEATH OCCURRED IN THE STUDY POPULATION; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN ANY MEDTRONIC PRODUCT AND THE DEATH. THE REPORTED CAUSE OF DEATH WAS HEMORRHAGIC CONVERSION FOLLOWING MECHANICAL THROMBECTOMY (N = 1). AMONG ALL STUDY PATIENTS, ADVERSE EVENTS INCLUDED TRANSIENT SYMPTOMATIC SPASM (TEMPORARY BLOOD VESSEL SPASM), SYMPTOMATIC HEMORRHAGE, AND CONVERSION FROM RADIAL TO FEMORAL ACCESS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761335 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK FLEX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Death