BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 24791011 · Received April 6, 2026

    Report

    Report Number
    2029214-2026-00609
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Date of Event
    April 1, 2026
    Report Date
    May 19, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00763000254704
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP WILL BE SENT ONCE ANALYSIS IS COMPLETE. 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

    CONTINUATION OF D10: PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT PRODUCT ID PED2-350-25 (LOT D060828);  PHENOM 27 MICROCATHETER PRODUCT ID UNK-NV-FG15 (LOT  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

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSES OR CONTRIBUTING FACTORS FOR THE RESISTANCE, DAMAGE, AND PRE MATURE DEPLOYMENT WERE NOT IDENTIFIED. IT WAS STATED THAT SIGNIFICANT RESISTANCE WAS FELT DURING ADVANCEMENT AND UNABLE TO GO FURTHER, A WITHDRAWAL MANEUVER WAS PERFORMED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT 2 PIPELINE FLEX WITH SHIELD TECHNOLOGY STENTS ENCOUNTERED RESISTANCE IN A PHENOM 27 MICROCATHETER. ONE WAS DEFORMED AND THE OTHER DEPLOYED PREMATURELY. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, ANEURYSM AT THE BASILAR ARTERY TIP WITH A MAX DIAMETER OF 3.6 MM AND A 2.5 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 3.4 MM DISTALLY AND 3.6 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. POST-OPERATIVE VASCULAR IMAGING WAS REPORTED AS NORMAL. THE ACCESS SYSTEM WAS SUCCESSFULLY ESTABLISHED VIA A PUNCTURE OF THE RIGHT RADIAL ARTERY, WITH THE INTERMEDIATE CATHETER ADVANCED TO THE V3 SEGMENT. A MICRO-GUIDEWIRE WAS USED TO GUIDE A PHENOM 27 MICROCATHETER INTO THE LEFT POSTERIOR CEREBRAL ARTERY. THE FIRST FLOW-DIVERTING STENT (PED2-375-20) WAS SELECTED; AFTER ENSURING ADEQUATE INJECTING OF THE SHEATH WITH 5¿8 DROPS OF SALINE, THE STENT WAS ADVANCED INTO THE PHENOM 27 MICROCATHETER. AFTER ADVANCING IT 10¿15 CM (MID-CATHETER), THE SURGEON REPORTED SIGNIFICANT RESISTANCE DURING INSERTION AND DIFFICULTY WITH RETRACTION. UPON WITHDRAWING THE STENT, IT WAS FOUND TO BE COMPLETELY DEFORMED AND UNUSABLE. CONSEQUENTLY, A SECOND FLOW-DIVERTING STENT (PED2-350-25) WAS USED INSTEAD; AFTER THOROUGH INJECTING SALINE, THE STENT WAS ADVANCED INTO THE MICROCATHETER. THE SURGEON AGAIN REPORTED DIFFICULTY WITH INSERTION; UPON WITHDRAWAL, THE STENT WAS FOUND TO HAVE FULLY DEPLOYED AND COULD NOT BE USED. SUBSEQUENTLY, A DIFFERENT MODEL OF STENT MICROCATHETER AND FLOW-DIVERTING STENT WERE USED INSTEAD. FOLLOWING THE IMPLANTATION OF THE STENT IN THE LEFT POSTERIOR CEREBRAL ARTERY AND BASILAR ARTERY, THE CONDITION WAS SATISFACTORY, AND THE PROCEDURE WAS CONCLUDED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL). THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. THE PIPELINE STENTS DID NOT BECOME STUCK. THE FIRST STENT PED2-375-20 PUSHWIRE AND CONCOMITANT CATHETER WERE NOT DAMAGED. THE SECOND STENT PED2-350-25 PUSHWIRE WAS NOT DAMAGED, HOWEVER, THE PROXIMAL SECTION OF THE MICROCATHETER WAS OBSERVED TO BE DAMAGED DESCRIBED AS EDGE BURRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147954 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-375-20 D048644 00763000254704

    Patients

    Seq Age Sex Outcome Treatment
    1