BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE VANTAGE WITH SHIELD TECHNOLOGY

    MDR report key: 21350019 · Received February 10, 2025

    Report

    Report Number
    2029214-2025-00356
    Event Type
    Injury
    Date Received
    February 10, 2025
    Date of Event
    September 28, 2024
    Report Date
    July 21, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00847536035423
    PMA / PMN Number
    P100018
    Removal / Correction Number
    Z-1245-2025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID FG15150-0615-1S (LOT: 226845530) ; IMPLANT DATE N/A; EXPLANT DATE N/A. 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

    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

    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

    IT WAS REPORTED THAT A PATIENT TREATED OFF-LABEL FOR A CERVICAL INTERNAL CAROTID ARTERY DISSECTING ANEURYSM WITH A PIPELINE VANTAGE WITH SHIELD TECHNOLOGY EXPERIENCED SYMPTOMS OF HEADACHE, DIZZINESS, AND LOSS OF BALANCE. THE ANEURYSM EMBOLIZATION WAS PERFORMED USING A 4.0MM X 30MM PIPELINE VANTAGE AND COILS. THE ANEURYSM DIMENSIONS MEASURED A MAX DIAMETER OF 8, 9 MM AND NECK DIAMETER OF 3, 6 MM. LANDING ZONE: DISTAL: 4, 1MM AND PROXIMAL 3,3 MM. VESSEL TORTUOSITY WAS MINIMAL. INITIALLY, THE PATIENT SHOWED GOOD RECOVERY AND RESOLUTION OF SYMPTOMS. HOWEVER, FIVE MONTHS POST-TREATMENT, WHILE AWAITING A CONTROL DSA, THE PATIENT EXPERIENCED A RECURRENCE OF SYMPTOMS. A CTA REVEALED SEVERE STENOSIS IN THE STENT, AND A SUBSEQUENT DSA SHOWED STENT DEFORMATION AND SEVERE NEOINTIMAL HYPERPLASIA. IT WAS REPORTED THE PIPELINE FAILED TO OPEN IN THE MIDDLE SECTION. A BALLOON-MOUNTED STENT ANGIOPLASTY WAS PERFORMED TO RESTORE PROPER FLOW. THE PATIENT WAS ADMINISTERED DUAL ANTIPLATELET TREATMENT, AND HOSPITALIZATION WAS EXTENDED BY FIVE DAYS. THE PIPELINE WAS NOT POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES. THE PIPELINE WAS NOT REMOVED FROM THE PATIENT. FULL WALL APPOSITION WAS ACHIEVED. THE ANGIOGRAPHIC RESULT POST-PROCEDURE INDICATED GOOD RECOVERY AND RESOLUTION OF SYMPTOMS. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT. ANCILLARY DEVICES INCLUDED: BMX 096 PENUMBRA SHEATH, PHENOM 27 MICROCATHETER, PORTAL 0.014 PHENOX GUIDEWIRE, 2 NUMEN MICROPORT COILS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE FAILURE TO OPEN WAS DUE TO SEGMENTAL STENOSIS ASSOCIATED WITH THE ARTERY DISSECTION, CORRECTED WITH BALLOON ANGIOPLASTY. THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THE PIPELINE WAS SUCCESSFULLY IMPLANTED AND A SEGMENTAL STENOSIS HAD TO BE CORRECTED, IT WAS NOT INTERPRETED AS FAILED DEVICE OPENING. THE PATIENT BEGAN HAVING THE RECURRING SYMPTOMS IN (B)(6) 2024. BALLOON ANGIOPLASTY FOLLOWED BY IN-STENT STENOSIS CORRECTION USING BALLOON-MOUNTED STENT ON (B)(6) 2024. THERE WERE NO ISSUE WITH THE PHENOM CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1753303 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED3-027-400-30 B415343 00847536035423

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention| H SEE H11...