BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 24549722 · Received March 9, 2026

    Report

    Report Number
    2029214-2026-00392
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    July 11, 2025
    Report Date
    March 9, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION/LINK: FENG, X., HUANG, C., TONG, X., WEN, Z., ZHU, Y., HUANG, M., LIN, J., HUANG, J., YUAN, H., XU, A., MA, G., GE, R., LI, C., PENG, C., SU, S., ZHANG, X., LI, X., GUO, Z., LIU, A., DUAN, C. (2025). EFFECT OF LDL-CHOLESTEROL LEVELS AND ORAL ATORVASTATIN ON OUTCOMES AFTER PIPELINE THERAPY FOR INTRACRANIAL ANEURYSMS. STROKE, 56(10), 3002¿3013. HTTPS://DOI.ORG/10.1161/STROKEAHA.124.049833 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 THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION 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

    FENG, X., HUANG, C., TONG, X., WEN, Z., ZHU, Y., HUANG, M., LIN, J., HUANG, J., YUAN, H., XU, A., MA, G., GE, R., LI, C., PENG, C., SU, S., ZHANG, X., LI, X., GUO, Z., LIU, A., DUAN, C. (2025). EFFECT OF LDL-CHOLESTEROL LEVELS AND ORAL ATORVASTATIN ON OUTCOMES AFTER PIPELINE THERAPY FOR INTRACRANIAL ANEURYSMS. STROKE, 56(10), 3002¿3013. HTTPS://DOI.ORG/10.1161/STROKEAHA.124.049833 LITERATURE WAS REVIEWED REGARDING THE IMPACT OF STATIN THERAPY ON ANGIOGRAPHIC AND CLINICAL OUTCOMES FOLLOWING TREATMENT OF INTRACRANIAL ANEURYSMS WITH THE PIPELINE EMBOLIZATION DEVICE. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION AS PART OF ROUTINE ENDOVASCULAR PRACTICE. THE FOLLOWING MEDTRONIC DEVICES WERE USED: PIPELINE EMBOLIZATION DEVICE. DEATHS OCCURRED IN THE STUDY POPULATION; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN THE MEDTRONIC PRODUCT AND THE DEATHS. THE CAUSES OF DEATH WERE NOT PROVIDED. AMONG ALL PIPELINE PATIENTS, ADVERSE EVENTS / DEVICE PRODUCT PERFORMANCE ISSUES INCLUDED: - ARTERIAL PERFORATION: 4 PATIENTS - IN-STENT STENOSIS: 134 PATIENTS PERIOPERATIVE / PROCEDURAL COMPLICATIONS - CEREBROVASCULAR COMPLICATIONS (ANY): 72 PATIENTS - POSTOPERATIVE ISCHEMIC EVENTS (ANY): 47 PATIENTS - MINOR ISCHEMIC STROKE: 16 PATIENTS - MAJOR ISCHEMIC STROKE: 6 PATIENTS - TRANSIENT ISCHEMIC ATTACK (TIA): 27 PATIENTS - POSTOPERATIVE HEMORRHAGIC EVENTS (ANY): 23 PATIENTS - IN-STENT THROMBOSIS: 7 PATIENTS POST-OPERATIVE / FOLLOW-UP COMPLICATIONS - ISCHEMIC COMPLICATIONS DURING FOLLOW-UP: 44 PATIENTS - HEMORRHAGIC COMPLICATIONS DURING FOLLOW-UP: 10 PATIENTS - SYMPTOMATIC: 30 PATIENTS - UNFAVORABLE (MRS SCORE GREATER THAN 2): 22 PATIENTS - COMPOSITE EVENTS: 57 PATIENTS NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2943 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NV UNK PIPELINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention