BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 8116343 · Received November 29, 2018

    Report

    Report Number
    2029214-2018-00998
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Date of Event
    November 15, 2018
    Report Date
    February 27, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PIPELINE FLEX WITH SHIELD WAS RETURNED FOR EVALUATION WITHOUT THE HEADWAY 027 CATHETER. THE DISTAL AND PROXIMAL DPS RESTRAINTS WERE FOUND TO BE INTACT. THE DPS SLEEVES WERE FOUND INTACT WITH NO SIGNS OF DAMAGE. THE OUTER DIAMETER (O.D) OF THE RE-SHEATHING PAD WAS MEASURED WITHIN SPECIFICATIONS. THE DISTAL HYPOTUBE APPEARED TO BE STRETCHED WITH THE PTFE SHRINK TUBING STILL INTACT. THE PIPELINE FLEX WITH SHIELD BRAID WAS RETURNED DETACHED FROM THE PUSHWIRE; THEREFORE, THE DISTAL AND PROXIMAL ENDS OF THE BRAID WERE UNABLE TO BE IDENTIFIED. THE PIPELINE FLEX WITH SHIELD BRAID APPEARED TO BE FULLY OPENED AND MODERATELY FRAYED AT BOTH ENDS. THE PUSHWIRE WAS FOUND BENT AT MULTIPLE LOCATION. NO DAMAGES WERE FOUND WITH THE TIP COIL, DISTAL MARKER, RE-SHEATHING MARKER, RE-SHEATHING PAD OR WITH THE PROXIMAL BUMPER. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE ANALYSIS FINDINGS, THE REPORT OF ¿FAILURE TO OPEN¿ ISSUE, THE COMPLAINT WAS NOT CONFIRMED AS THE RETURNED PIPELINE FLEX WITH SHIELD BRAID FOUND FULLY OPENED AND MODERATELY FRAYED AT BOTH ENDS. FROM THE DAMAGES SEEN ON THE PUSHWIRE: PROXIMAL WIRE (BENDING), PIPELINE FLEX BRAID (FRAYING) AND HYPOTUBE (STRETCHING); IT APPEARS THERE WAS HIGH FORCE USED (PUSHING AND PULLING). IT IS LIKELY THESE DAMAGES OCCURRED WHEN THE USER ATTEMPTED TO NAVIGATE THE PIPELINE FLEX WITH SHIELD THROUGH THE CATHETER AGAINST RESISTANCE. THE DAMAGE TO THE ENDS OF THE PIPELINE FLEX WITH SHIELD BRAID IS LIKELY THE RESULTS OF THE PHYSICIAN RE-SHEATHING THE DEVICE MORE THAN RECOMMENDED TWO TIMES. IT WAS REPORTED THAT THE DEVICES WERE PREPARED PER THE IFU AND CONTINUOUS FLUSH WITH HEPARINIZED SALINE WAS MAINTAINED DURING DELIVERY. IN ADDITION, THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT'S POSSIBLE THAT THE ¿SEVERE VESSEL TORTUOSITY¿ MAY HAVE CONTRIBUTED THE ¿RESISTANCE¿ AND ¿FAILED TO OPEN¿ ISSUES. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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 A REPORT THAT THE PIPELINE WAS BROUGHT THROUGH THE CATHETER WITH A LOT OF TENSION. ONCE THE PIPELINE WAS IN POSITION TO DEPLOY THE PHYSICIAN PULLED BACK TO RELIEVE TENSION AND DEPLOYED UNTIL THE PROXIMAL END PORTION. AT THIS POINT THE PROXIMAL END WAS TWISTED ON BOTH PLANES OF IMAGING, SO RESHEATHING AND UNSHEATHING WERE ATTEMPTED THREE TIMES. THIS INCLUDED TWO FULL RESHEATHS AND ONE MID STENT RESEATH, AND ON THE LAST ATTEMPT THERE WERE MANY TRIES OF PUSHING AND PULLING THE SYSTEM TO TRY AND OPEN THE STENT. THE STENT WAS THEN FULLY RESHEATED AND TAKEN OUT DUE TO THE FAILURE TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR LICA - PCOM ANEURYSM.DUAL ANTIPLATELET TREATMENT WAS ADM INISTERED, AND A GOOD ANGIOGRAPHIC RESULT WAS SEEN AFTER PROCEDURE. THE VESSEL WAS SEVERELY TORTUOUS. IT WAS NOTED THAT THE PIPELINE WAS POSITIONED IN A BEND AT THE PROXIMAL PORTION, AND THAT MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. ANCILLARY DEVICES INCLUDE A HEADWAY27 MICROCATHETER.

    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 PIPELINE WAS BROUGHT THROUGH THE CATHETER WITH A LOT OF TENSION. ONCE THE PIPELINE WAS IN POSITION TO DEPLOY THE PHYSICIAN PULLED BACK TO RELIEVE TENSION AND DEPLOYED UNTIL THE PROXIMAL END PORTION. AT THIS POINT THE PROXIMAL END WAS TWISTED ON BOTH PLANES OF IMAGING, SO RESHEATHING AND UNSHEATHING WERE ATTEMPTED THREE TIMES. THIS INCLUDED TWO FULL RESHEATHS AND ONE MID STENT RESEATH, AND ON THE LAST ATTEMPT THERE WERE MANY TRIES OF PUSHING AND PULLING THE SYSTEM TO TRY AND OPEN THE STENT. THE STENT WAS THEN FULLY RESHEATED AND TAKEN OUT DUE TO THE FAILURE TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR LICA - PCOM ANEURYSM. DUAL ANTIPLATELET TREATMENT WAS ADM INSERTED, AND A GOOD ANGIOGRAPHIC RESULT WAS SEEN AFTER PROCEDURE. IT WAS NOTED THAT THE PIPELINE WAS POSITIONED IN A BEND AT THE PROXIMAL PORTION, AND THAT MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. ANCILLARY DEVICES INCLUDE A (B)(4) MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957098 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA PED2-400-18 A357190

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR