BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 15081003 · Received July 21, 2022

    Report

    Report Number
    2029214-2022-01214
    Event Type
    Malfunction
    Date Received
    July 21, 2022
    Date of Event
    July 15, 2022
    Report Date
    October 28, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED TO REGULATORY REPORT#: 2029214-2022-01213. 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 · 0

    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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT 2 PED2 PIPELINES FAILED TO OPEN. AND HAD RESISTANCE IN THE PHENOM CATHETER. PATIENT WAS BROUGHT IN ON A FOR ECR. HOWEVER, THE CAROTID WAS TORTUROUS, APPEARED TO HAVE DISSECTION AND WAS POSSIBLY THROWING OFF CLOT AND THEREFORE NEEDING STENTING. DOCTOR DECIDED ITS BEST TO STENT THE CAROTID WITH PIPELINE SHIELD -POSSIBLY TELESCOPE. PRIOR TO CONDUCTING ECR. PREPPED FIRST PED2 AS PER IFU INSTRUCTIONS AND PROCEEDED WITH DEPLOYMENT. HOWEVER, THE DISTAL END WOULDN'T OPEN. WITH FAILURE OF OPENING, DOCTOR PULLED IT OUT AND GOT ANOTHER PED2 DEVICE (BOTH ARE THE SAME SIZE WITH THE SAME LOT #). SECOND PED2, WAS PREPPED AS PER INSTRUCTIONS FOR USE (IFU) INSTRUCTIONS AND DOCTOR HAD THE SAME ISSUE AS PREVIOUS WHERE THE DISTAL END OF STENT WOULD OPEN AND GOT STUCK IN THE PHENOM MICROCATHETER. HAD TO PULL OUT WHOLE SYSTEM. BELIEVED DR THE PULLED OUT A SLIGHTLY SMALLER STENT AND DEPLOYED IT MORE DISTAL TO LESION AND TELESCOPED. CASE PROCEEDED WITH ECR AND PATIENT IS DOING OKAY. THE RESISTANCE IN THE CATHETER HAS IN THE DISTAL SECTION. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. THE PIPELINE BECAME STUCK DURING DEPLOYMENT. THE PHYSICIAN RELEASED TO LOAD IN THE SYSTEM IN AN ATTEMPT TO RESOLVE THE ISSUE. THE ISSUE DID NOT RESOLVE. THE CATHETER AND PUSHWIRE WERE NOT DAMAGED. THE DEVICE FAILED TO OPEN IN THE DISTAL SECTION. THE PIPELINE WAS NOT PLACED IN A BEND. LESS THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. NO ADDITIONAL STEPS WERE TAKEN TO REMOVE THE PIPELINE. THE PIPELINE WAS REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THE DISTAL LANDING ZONE AND ACCESS VESSEL WAS 475MM AND THE PROXIMAL LANDING ZONE WAS 5MM. THE ACCESS VESSEL DIAMETER WAS 5MM. VESSEL TORTUOSITY WAS SEVERE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106021 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-500-35 B268612

    Patients

    Seq Age Sex Outcome Treatment
    1 Male