BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3770652 · Received April 24, 2014

    Report

    Report Number
    2029214-2014-00226
    Event Type
    Death
    Date Received
    April 24, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THE PIPELINE REMAINS IN THE PATIENT WITH THE BROKEN DISTAL PUSHWIRE ATTACHED TO IT. THE BROKEN PROXIMAL SEGMENT OF THE PUSHWIRE WAS DISCARDED. (B)(4).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP TYPE - ADDITIONAL INFORMATION BASED ON THE REPORTED INFORMATION, THE USER CONTRIBUTED TO THE DEVICE DISLODGMENT TO AN UNINTENDED LOCATION AND SUBSEQUENTLY DIFFICULTIES IN REMOVING THE DEVICE FROM THE PATIENT. PER PIPELINE EMBOLIZATION DEVICE (PED) INSTRUCTION FOR USE: - WHILE ADVANCING THE PED INSIDE THE MICROCATHETER, DO NOT PULL BACK ON OR TORQUE THE WIRE. THIS MAY MAKE DEVICE RELEASE MORE DIFFICULT OR IMPOSSIBLE. - ROTATE THE DELIVERY WIRE ONLY IN A CLOCKWISE DIRECTION. ROTATING IN A COUNTER-CLOCKWISE DIRECTION MAY MAKE DEVICE RELEASE MORE DIFFICULT OR IMPOSSIBLE. - PUSH THE DELIVERY WIRE AND/OR UNSHEATHE THE PED TO CONTINUE TO EXPOSE THE PED. AFTER SEVERAL MILLIMETERS OF PED ARE EXPOSED, THE DISTAL END MAY DETACH FROM THE DELIVERY WIRE. DETACHMENT CAN BE FACILITATED BY SLOWLY ROTATING THE DELIVERY WIRE IN THE CLOCKWISE DIRECTION AND/OR MANIPULATING THE MICROCATHETER BY LOCKING DOWN THE DELIVERY WIRE AND MOVING BOTH AS A SYSTEM. - A PARTIALLY DEPLOYED PED CAN BE RETRIEVED. CAREFULLY PULL BACK THE DELIVERY CORE WIRE UNTIL THE PED IS SECURED AT THE TIP OF THE MICROCATHETER. THEN, IF THERE IS NO RESISTANCE, SIMULTANEOUSLY REMOVE THE ENTIRE SYSTEM (MICROCATHETER AND DELIVERY SYSTEM). - ONCE FULLY DEPLOYED, THE PED CANNOT BE REMOVED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IDENTIFIER IS (B)(4) AND THE USER UF/IMPORTER REPORT# IS (B)(4). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE PIPELINE AND PUSHWIRE INTO POSITION OF THE UNRUPTURED ANEURYSM LOCATED IN THE LEFT ICA (INTERNAL CAROTID ARTERY). THE PHYSICIAN ATTEMPTED TO ROTATE THE PUSHWIRE TO RELEASE THE PIPELINE FROM THE CAPTURE COIL, BUT ENCOUNTERED DIFFICULTY DURING THE ROTATION AND NOTICED A KINK IN THE PUSHWIRE. AN ATTEMPT WAS MADE TO RETRIEVE THE PIPELINE AND PUSHWIRE, BUT WITHOUT SUCCESS. A DECISION WAS MADE TO SEVER THE PUSHWIRE AND CAPTURE COIL, THEREFORE LEAVING THEM INSIDE THE PATIENT. THE FOLLOWING DAY POST PROCEDURE, THE PATIENT'S CONDITION SHOWED DETERIORATION WITH A CT (COMPUTED TOMOGRAPHY) CONFIRMING INTERVAL DEVELOPMENT OF PARENCHYMAL HEMORRHAGE WITHIN THE LEFT BASAL GANGLIA ALONG WITH DIFFUSED SAH (SUBARACHNOID HEMORRHAGE). CEREBRAL ANGIOGRAM SHOWED SENT COIL LEFT ICA RUPTURED ANEURYSM. A RIGHT EVD (EXTERNAL VENTRICULAR DRAIN) WAS PLACED. ON (B)(6) 2014 POST PROCEDURE DAY TWO, THE PATIENT DEVELOPED CEREBRAL ISCHEMIA AND POSSIBLE TRANSTENTORIAL HERNIATION. AS A RESULT OF THE HEMORRHAGE, THE PATIENT DEVELOPED CEREBRAL EDEMA, REQUIRING A CRANIECTOMY. SUBSEQUENTLY, THE PATIENT EXPIRED ON (B)(6) 2014. UPDATED PART UPDATED (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT A PIPELINE COULD NOT BE RELEASED FROM THE CAPTURE COIL, WAS DISLODGED TO A MORE DISTAL LOCATION DURING A REMOVAL ATTEMPT, AND WAS LEFT IN THE PATIENT IN AN UNINTENDED LOCATION. BASED ON THE MEDICAL RECORD, THE PATIENT WAS TREATED FOR A LARGE, UNRUPTURED ANEURYSM IN THE LEFT SUPRACLINOID INTERNAL CAROTID ARTERY (ICA). THE CT SCAN PRIOR TO THE PIPELINE PROCEDURE WAS NEGATIVE; HOWEVER THERE WAS QUESTIONABLE SENTINEL BLOOD. ACCORDING TO THE PROCEDURE NOTE, THE PHYSICIANS USED A TRIAXIAL SYSTEM TO CATHETERIZE THE LEFT MIDDLE CEREBRAL ARTERY (MCA) AND DELIVER THE PIPELINE. IT WAS REPORTED THAT DURING DEPLOYMENT, THE DISTAL ASPECT OF THE STENT, WHICH IS A "CATHETER COIL", WAS NOT COMPLETELY EXPOSED. THE PHYSICIAN ATTEMPTED TO BRING THE CATHETER UP INTO THE DISTAL ASPECT OF THIS PIPELINE. IN THE PROCESS, IT ACTUALLY BROUGHT THE PIPELINE CATHETER FROM THE ICA INTO THE MCA AND STRETCHED IT. THE PHYSICIANS WERE UNABLE TO DEPLOY THE CAPTURE COIL. IT WAS THE CAPTURE COIL THAT WAS CAPTURING THE DISTAL ASPECT OF THE STENT, BUT NEVER ACTUALLY RELEASED. THE PHYSICIANS WERE UNABLE TO PULL THE WIRE OUT COMPLETELY BECAUSE IT WAS ATTACHED TO THE CAPTURE COIL. AFTER MULTIPLE ATTEMPTS, THE PHYSICIANS TRIED TO USE A CORONARY BALLOON, 8MMX2MM, OVER A STRETCH WIRE TO OPEN THE BALLOON AT THE DISTAL ASPECT TO SEE IF IT COULD RELEASE THE STENT. AFTER ABOUT 2-2 1/2 HOURS OF ATTEMPTING, THE PHYSICIANS PERFORMED ANGIOGRAM AND OBSERVED A DECREASED FLOW IN THE DISTAL LEFT ICA. THEREFORE, THE PHYSICIANS DECIDED TO CAPTURE THE STENT BACK IN PLACE USING A GOOSENECK MICROSNARE 7MMX200 CM OVER THE CATHETER. DURING THIS PROCESS THE PHYSICIANS WERE ABLE TO BREAK OFF THE WIRE THAT WAS ATTACHED TO THE PIPELINE. THE PIPELINE WAS TWISTED INSIDE THE MIDDLE CEREBRAL ARTERY AND AT THAT POINT, THE PHYSICIANS MADE THE DECISION TO LEAVE IT IN PLACE AND TO PASS THE MICROWIRE THROUGH IT, SO SACRIFICING A BRANCH OF THE MCA ARTERY. THE PHYSICIANS CONTINUED TO TREAT THE PATIENT WITH ASPIRIN AND CLOPIDOGREL. THE PATIENT WAS ALREADY ON HEPARIN DURING THE PROCEDURE KEEPING THE ACTIVATED CLOTTING TIME ( ACT) 2 TO 2 1/2 TIMES THE NORMAL LEVELS. THE PHYSICIANS WERE ASSURED THAT THERE IS GOOD FLOW THROUGH THE ANTERIOR CEREBRAL ARTERY (ACA) FROM THE RIGHT SIDE. ACCORDING TO THE MEDICAL RECORD, ONE DAY POST PROCEDURE, THE PATIENT EXPERIENCED ALTERED LEVEL OF CONSCIOUSNESS AND WAS FOUND TO HAVE AN INTERVAL DEVELOPMENT OF PARENCHYMAL HEMORRHAGE CENTERED WITHIN THE LEFT BASAL GANGLIA ALONG WITH DIFFUSE SUBARACHNOID HEMORRHAGE. THE RUPTURED ANEURYSM WAS TREATED WITH STENT ASSISTED COILING AND PLACEMENT OF RIGHT EXTRA VENTRICULAR DRAINAGE. AFTER THIS PROCEDURE, THE PATIENT UNDERGONE AN EMERGENT LEFT-SIDED HEMICRANIECTOMY FOR DECOMPRESSION OF BRAIN TO TREAT A COMBINATION OF INCREASING PARENCHYMAL HEMATOMA LEFT BASAL GANGLIA AND INCREASING CEREBRAL EDEMA. THE PATIENT HAD DIAGNOSES OF CIRCULATORY SHOCK, HERNIATION OF THE BRAIN, RESPIRATORY FAILURE, AND OBSTRUCTIVE HYDROCEPHALUS AT THE TIME OF THE DEATH, 6 DAYS POST PIPELINE PROCEDURE.

    Description of Event or Problem · 1

    TREATMENT OF SMALL UNRUPTURED ANEURYSM MEASURING 8.9MM X 6.8MM LOCATED IN THE OPHTHALMIC SEGMENT OF THE LEFT ICA (INTERNAL CAROTID ARTERY). ON (B)(6) 2014, THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT. THE PATIENT WAS GIVEN DUAL ANTI-PLATELET THERAPY PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THE PIPELINE (4.50MM X 16MM) COULD NOT BE RELEASED FROM THE CAPTURE COIL DESPITE MANIPULATION OF THE PUSHWIRE AND ROTATING THE PUSHWIRE CLOCKWISE FOUR TIMES. THE PHYSICIAN WAS TOLD TO REMOVE THE ENTIRE SYSTEM (PIPELINE, MARKSMAN CATHETER, AND PUSHWIRE) AS A WHOLE; HOWEVER, ONLY THE MARKSMAN CATHETER WAS PULLED CAUSING THE PROXIMAL END OF THE PIPELINE TO DEPLOY AND ADHERE TO THE VESSEL WALL. A MAVERICK BALLOON WAS ADVANCED THROUGH THE OPEN PROXIMAL END OF THE PIPELINE TO THE DISTAL END IN AN ATTEMPT TO RELEASE IT FROM THE CAPTURE COIL, BUT WITHOUT SUCCESS. IT WAS NOTED AT THE TIME, THAT THE MAVERICK BALLOON MAY NOT HAVE BEEN INSIDE THE PIPELINE. A 4MM SNARE WAS THEN USED IN AN ATTEMPT TO RETRIEVE THE PIPELINE AS IT ENDED UP DISTAL TO THE ANEURYSM AT THE M1 AND M2 SEGMENT, BUT THE PUSHWIRE BROKE PROXIMALLY TO THE PIPELINE IN THE PROCESS. FURTHER ATTEMPTS WERE MADE TO SNARE THE PIPELINE AND BROKEN PUSHWIRE FROM THE PATIENT, BUT WITHOUT SUCCESS AND IT WAS DECIDED TO LEAVE THE PIPELINE WITH DISTAL PUSHWIRE ATTACHED INSIDE THE PATIENT. THE CATHETER AND PROXIMAL SEGMENT OF THE PUSHWIRE WERE REMOVED AND THE PATIENT WAS TRANSFERRED TO THE ICU (INTENSIVE CARE UNIT) AFTER WAKING UP. REOPRO WAS GIVEN TO THE PATIENT POST PROCEDURE. THE ANEURYSM WAS NOT TREATED AND THE PATIENT WAS REPORTED TO BE IN POOR CONDITION AND SUBSEQUENTLY EXPIRED APPROXIMATELY ONE WEEK AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249743 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) FA-77450-16 9856868

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death| H| R| S