BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE VANTAGE WITH SHIELD TECHNOLOGY

    MDR report key: 20455600 · Received October 15, 2024

    Report

    Report Number
    2029214-2024-01889
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    March 28, 2022
    Report Date
    October 25, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    MEDTRONIC RECEIVED A REPORT THAT A PATIENT WHO HAD BEEN IMPLANTED WITH A PIPELINE EXPERIENCED A SMALL SEMI-RECENT STROKE OF THE SEMI-OVAL CENTER. NO ADDITIONAL INTERVENTION OR HOSPITALIZATION WAS ADMINISTERED, AND THE EVENT RECOVERED/RESOLVED THE SAME DAY. THE EVENT RESULTED IN NEW OR WORSENING OF EXISTING NEUROLOGICAL DEFICITS WHICH LASTED FOR MORE THAN 24 HOURS. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE AND DAPT. THE PATIENT WAS UNDERGOING TREATMENT FOR THREE SACCULAR, SIDEWALL ANEURYSMS THE FIRST WAS LOCATED IN THE C6 SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER WAS 9.4MM, THE DOME HEIGHT WAS 6.9MM, THE DOME WIDTH WAS 6MM, AND THE NECK SIZE WAS 3.7MM. THE SECOND WAS LOCATED IN THE C6 SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER WAS 4.1MM, THE DOME HEIGHT WAS 2.3MM, THE DOME WIDTH WAS 3MM, AND THE NECK SIZE WAS 3MM. THE THIRD WAS LOCATED IN THE LEFT POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER WAS 3.2MM, THE DOME HEIGHT WAS 2.8MM, THE DOME WIDTH WAS 3.1MM, AND THE NECK SIZE WAS 1.9MM. THE PARENT ARTERY DIAMETER WAS 2.8MM DISTAL TO THE ANEURYSMS AND 3.9MM PROXIMAL. THE PIPELINE HAD BEEN SUCCESSFULLY IMPLANTED WITH WALL APPOSITION AND NECK COVERAGE ACHIEVED. ADDITIONAL INFORMATION RECEIVED REPORTED CORELAB REPORTED 50-75% PARENT ARTERY STENOSIS RESULTING IN ISCHEMIC WITH HEMORRHAGIC TRANSFORMATION, MULTIFOCAL BORDER ZONE INFARCT AT LEFT SIDE ON DIFFERENT TIME POINTS DUE TO THROMBUS AT DEVICE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED A SMALL SEMI-RECENT ISCHEMIC STROKE OF THE SEMI-OVAL CENTER. IT WAS NOTED THAT THE PATIENT RECOVERED/RESOLVED WITH SEQUELAE. PER TRANSMITTED SOURCE, 2 X PIPELINE VANTAGE 4X20 (BATCH# B240944 AND B186465) WERE OPENED DURING INDEX PROCEDURE. SITE QUERIED TO CLARIFY DISPOSITION OF THE PIPELINE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT PER SOURCE, 2 X VANTAGE 4X20 (BATCH# B240944 AND B186465) OPENED DURING INDEX PROCEDURE. SITE QUERIED TO CLARIFY DISPOSITION OF B240944. CEC ADJ AS POSSIBLE TO PROCEDURE, VANTAGE AND NOT RELATED TO DAPT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PED3-027-400-20 (B240944) WAS NOT IMPLANTED BECAUSE OF THE TORTUOSITY OF THE ARTERY WHICH DID NOT ALLOW THE PROPER OPENING OF THE FIRST STENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THE STENT DEPLOYMENT PROVED TO BE DIFFICULT DUE TO PRONOUNCED ARTERIAL LOOPS. NEVERTHELESS, DID MANAGE TO DEPLOY THE STENT THE PROXIMAL SECTION OF WHICH WAS NOT APPLIED PROPERLY TO THE ARTERIAL WALLS ON INITIAL INSPECTION. FOLLOWING MECHANICAL ANGIOPLASTY WITH A 4 X 15 MM HYPERGLIDE BALLOON GUIDED ON A XPEDION MICROGUIDE, PERFECT OPENING OF THE STENT WAS ACHIEVED, APPLIED PROPERLY TO THE ARTERIAL WALLS, WHILE MAINTAINING PATENCY IN THE OSTIUM OF THE LEFT ANTERIOR CHOROIDAL ARTERY. DEVICE HASN'T BEEN IMPLANTED BECAUSE OF THE TORTUOSITIES OF THE ARTERY, NOT ALLOWING THE PROPER OPENING OF THE FIRST STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319888 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY LASER THERAPY PRODUCT OUT MICRO THERAPEUTICS, INC. DBA EV3 PED3-027-400-20 B240944

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other