BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 11411579 · Received March 4, 2021

    Report

    Report Number
    2029214-2021-00242
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    February 18, 2021
    Report Date
    May 12, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS FINDINGS: A PIPELINE FLEX EMBOLIZATION DEVICE (MODEL: PED2-500-25 LOT: B043139) WAS RETURNED FOR ANALYSIS. NO BENDS OR KINKS WERE FOUND WITH THE PIPELINE FLEX PUSHWIRE. THE DISTAL HYPOTUBE WAS FOUND TO BE STRETCHED AND PTFE WERE FOUND TO BE PULLED BACK. THE PROXIMAL BUMPER, RE-SHEATHING MARKER AND RE-SHEATHING PAD WERE FOUND TO BE INTACT. THE DPS SLEEVES WERE FOUND TO BE INTACT. THE TIP COIL WAS FOUND TO BE INTACT. THE PROXIMAL AND DISTAL BRAID ENDS WERE FOUND TO BE OPENED AND FRAYED. NO OTHER DAMAGES OR ANOMALIES WERE FOUND. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿FAILURE/INCOMPLETE OPEN DISTAL¿ WAS UNABLE TO BE CONFIRMED AS THE PIPELINE FLEX BRAID PROXIMAL AND DISTAL ENDS WERE FOUND TO BE OPENED. POSSIBLE CAUSES COULD BE VESSEL TORTUOSITY OR RE-SHEATHING THE DEVICE MORE THAN THE RECOMMENDED TWO TIMES. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THAT THE DISTAL SEGMENT OF THE PIPELINE STENT WOULD NOT OPEN DESPITE ALL OF THE MANIPULATIONS PERFORMED. THE STENT WAS NOT POSITIONED IN A BEND, LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED, RESHEATHING WAS DONE LESS THAN 3 TIMES, AND NO ADDITIONAL STEPS OR OTHER DEVICES WERE USED IN AN ATTEMPT TO OPEN THE STENT. THE PIPELINE WAS REMOVED FROM THE PATIENT ALONG WITH THE MICROCATHETER. A REPLACEMENT PRODUCT WAS USED TO COMPLETE THE PROCEDURE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. POST-PROCEDURE ANGIOGRAPHIC RESULTS SHOWED THE SURPASS EVOLVE WAS IMPLANTED WITHOUT ANY COMPLICATION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 9 MM AND A 7 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS 325 MG ASPIRIN 2 DAYS PRIOR AND 75 MG CLOPIDOGREL 7 DAYS PRIOR. ANCILLARY DEVICES INCLUDE A  REBAR MICROCATHETER (LOT: A988715).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308263 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-500-25 B043139

    Patients

    Seq Age Sex Outcome Treatment
    1