BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 11817160 · Received May 13, 2021

    Report

    Report Number
    2029214-2021-00567
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    May 6, 2021
    Report Date
    August 3, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    PMA / PMN Number
    P100018.S026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) CORRECTED. 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

    H3: ANALYSIS OF THE PIPELINE FLEX W/ SHIELD EMBOLIZATION DEVICE (LOT NO. A890041) FOUND THAT THE HYPOTUBE WAS UNSTRETCHED AND UNDAMAGED WITH THE PTFE SHRINK TUBING STILL INTACT. NO DAMAGES WERE FOUND WITH THE DISTAL MARKER, RE-SHEATHING MARKER OR WITH THE PROXIMAL BUMPER. THE DISTAL AND PROXIMAL DPS RESTRAINTS WERE FOUND TO BE INTACT. THE DPS SLEEVES WERE FOUND INTACT WITH NO SIGNS OF DAMAGE. THE TIP COIL WAS FOUND INTACT. BOTH BRAID ENDS WERE FOUND TO HAVE COMPLETELY OPENED, DAMAGED, AND FRAYED. BASED ON THE ANALYSIS FINDINGS, THE CUSTOMER REPORT OF ¿FAILURE/INCOMPLETE OPEN DISTAL (FLEX)¿ COULD NOT BE CONFIRMED FOR BOTH PIPELINE FLEX W/ SHIELD DEVICES. POSSIBLE CAUSES ARE PATIENT VESSEL TORTUOSITY, DAMAGED BRAID, BRAID IMPROPERLY SIZED TO ANATOMY, BRAID WAS OVERSTRETCHED DURING DELIVERY, USER DEPLOYS BRAID IN VESSEL BRAID, PRESENCE OF OTHER INDWELLING STENTS OR INAPPROPRIATE ANATOMY. THE BRAIDS WERE FOUND DAMAGED. POTENTIAL CAUSES FOR BRAID DAMAGE ARE RESHEATHING MORE THAN 2 TIMES, HIGH FORCE DELIVERY, OVER-MANIPULATION, DELIVERING/RETRACTING DELIVERY WIRE AGAINST RESISTANCE, DEPLOYING/RESHEATHING BRAID AGAINST RESISTANCE, OR DAMAGE DURING RETURN SHIPPING AS THE BRAIDS WERE RETURNED ALREADY DEPLOYED AND OUT OF ITS PROTECTIVE INTRODUCER SHEATHS AND DISPENSER COILS. CUSTOMER REPORTED RESHEATHING PIPELINE MORE THAN TWO TIMES. CUSTOMER REPORTED PATIENT VESSEL TORTUOSITY AS NORMAL, DEVICES WERE PREPARED AND FLUSHED PER IFU. THERE IS NO INDICATION THAT THE EVENT IS RELATED TO A POTENTIAL MANUFACTURING ISSUE. THERE WAS NO DAMAGES OR IRREGULARITIES FOUND WITH THE PHENOM-27 THAT WOULD CONTRIBUTE TOWARDS THE INCOMPLETE OPEN. H6: METHOD CODE UPDATED TO B01. RESULT CODE UPDATED TO C070601. CONCLUSION CODE UPDATED TO D15. 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. 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 TWO PIPELINES DID NOT OPEN DISTALLY EVEN AFTER SEVERAL RESHEATING MULTIPLE TIMES. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE ICA. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS RADIAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED AT USUAL LEVELS. IT WAS REPORTED THAT THE PIPELINES WERE NOT POSITIONED IN A BEND, AND MORE THAN 50% OF THEM WERE DEPLOYED WHEN THEY FAILED TO OPEN. THE PHYSICIAN HAD RESHEATHED THE PIPELINE MORE THAN TWO TIMES. NO OTHER STEPS WERE TAKEN TO OPEN THE DEVICES. THE PIPELINES WERE RESHEATHED, REMOVED FROM THE PATIENT, AND REPLACED. OUT OF THE PATIENT, THE PHYSICIAN PUSHED OUT THE 2 PIPELINES AND SAW FIBRIN ON THE FIRST STENT. ANGIOGRAPHIC RESULTS POST PROCEDURE WERE SAID TO BE OK. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A PHENOM 27 MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718432 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED2-450-12 A890041

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR