BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3722706 · Received April 2, 2014

    Report

    Report Number
    2029214-2014-00188
    Event Type
    Death
    Date Received
    April 2, 2014
    Date of Event
    November 16, 2012
    Report Date
    March 7, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2014 STATING THAT THE RELATIONSHIP OF THE ADVERSE EVENT THAT OCCURRED ON (B)(6) 2012 WITH SYMPTOMS OF LETHARGY, LIMITED VERBAL RESPONSE, DIFFICULTY FOLLOWING COMMANDS ESPECIALLY ON THE LEFT SIDE WITH DRIFT IN THE LEFT UPPER EXTREMITY AND UNABLE TO LIFT LEG WITHOUT ASSISTANCE (IMAGING REVEALED ACUTE TRAUMATIC PLAVIX ASSOCIATED SUBDURAL HEMATOMA WITH SOME RIGHT-TO-LEFT MIDLINE SHIFT) WAS ADJUDICATED FROM DEVICE RELATED TO OTHER. ALSO THE RELATIONSHIP OF THE ADVERSE EVENT THAT OCCURRED ON (B)(6) 2013 WITH SYMPTOMS OF INCREASED LETHARGY AND ALTERED MENTAL STATUS (IMAGING REVEALED ENLARGEMENT OF A LEFT CEREBRAL SUBDURAL HEMATOMA) WAS ADJUDICATED FROM PROCEDURE RELATED TO OTHER. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ASPIRE PROSPECTIVE REGISTRY, SUBJECT ID: (B)(6): TREATMENT OF A LARGE UNRUPTURED, SIDEWALL SACCULAR, PARTIALLY THROMBOSED, ANEURYSM MEASURING 14MM X 5.7 MM LOCATED IN THE CAVERNOUS SEGMENT OF THE RIGHT ICA (INTERNAL CAROTID ARTERY). THE PATIENT PRESENTED WITH NEUROLOGICAL SYMPTOMS OF THE SENSATION OF SHARP TINGLING ON THE TOP RIGHT SIDE OF THE HEAD. ON (B)(6) 2012, A SIDE BRANCH ORIGINATING FROM THE ANEURYSM SAC MEASURING 1.2 MM WAS COVERED BY THE PIPELINE (16 MM X 5 MM). THE PATIENT WAS PLACED ON ANTICOAGULANT THERAPY PRIOR TO THE PROCEDURE AND WAS GIVEN HEPARIN INTRAOPERATIVELY. DURATION OF THE PROCEDURE WAS 1 HOUR 50 MINUTES. POST-OPERATIVE ANGIOGRAM REVEALED A RESIDUAL ANEURYSM AND NO COMPLICATIONS WERE NOTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED A MILD, NON-SERIOUS ADVERSE EVENT OF 'POINTED' PAIN FROM TIME TO TIME IN THE LOCATION OF THE ANEURYSM. THIS EVENT WAS RESOLVED WITHOUT INTERVENTION ON (B)(6) 2012. THE EVENT WAS NOTED AS PROCEDURE RELATED. ON (B)(6) 2012, THE PATIENT EXPERIENCED A MILD, NON-SERIOUS ADVERSE EVENT OF "SUDDEN, SHARP PAIN, ON THE RIGHT SIDE OF HEAD". THE EVENT WAS RESOLVED ON (B)(6) 2013 WITHOUT INTERVENTION. ON (B)(6) 2012, THE PATIENT EXPERIENCED A SEVERE, SERIOUS ADVERSE EVENT OF ACUTE TRAUMATIC PLAVIX ASSOCIATED SUBDURAL HEMATOMA. THE PATIENT WAS BROUGHT INTO THE ER AFTER TWO FALLS AT HOME AND IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED FLU-LIKE SYMPTOMS OVER THE PAST FEW DAYS. THE PATIENT WAS AWAKE AND ALERT AND DID NOT LOSE CONSCIOUSNESS AFTER BOTH FALLS; HOWEVER, THE PATIENT WAS FOUND TO BE FEBRILE PRIOR TO TRANSPORTATION TO THE ER. UPON ARRIVAL AT THE ER THE PATIENT WAS ALERT AND ORIENTED. APPROXIMATELY ONE AND ONE HALF HOURS LATER THE PATIENT BECAME LETHARGIC WITH LIMITED VERBAL RESPONSE AND DIFFICULTY FOLLOWING COMMANDS ESPECIALLY ON THE LEFT SIDE WITH DRIFTS IN THE LEFT UPPER EXTREMITY AND UNABLE TO LIFT THE LEFT LEG WITHOUT ASSISTANCE. CT (COMPUTED TOMOGRAPHY) ON (B)(6) 2012, REVEALED A SUBDURAL HEMATOMA MEASURING 2 CM IN MAXIMAL THICKNESS WITH SOME RIGHT-TO-LEFT MIDLINE SHIFT. AN URGENT CRANIOTOMY AND EVACUATION OF THE SDH (SUBDURAL HEMATOMA) WAS PERFORMED. ON (B)(6) 2012, A CT REVEALED WORSENING WITH REBLEEDING INTO THE RIGHT HEMISPHERIC SUBDURAL HEMATOMA WITH MASS EFFECT UPON THE RIGHT FRONTAL, PARIETAL, AND TEMPORAL LOBES. ON (B)(6) 2012, THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR RE-EVACUATION OF THE SUBDURAL HEMATOMA AFTER DRAIN REMOVAL. THE PATIENT DEVELOPED INFLUENZA AND WAS TREATED WITH TAMIFLU PRIOR TO DISCHARGE ON (B)(6) 2013. UPON DISCHARGE THE PATIENT HAD A GCS (GLASGOW COMA SCALE) OF 15 WITH INTACT CRANIAL NERVES, NO DRIFT AND FULL RANGE OF MOTION. THE EVENT WAS NOTED AS DEVICE RELATED. ON (B)(6) 2013, THE SUBJECT EXPERIENCED A SEVERE, SERIOUS ADVERSE EVENT OF LEFT SUBDURAL HEMATOMA AND WAS ADMITTED TO THE ER WITH SYMPTOMS OF INCREASED LETHARGY AND ALTERED MENTAL STATUS. A CT REVEALED ENLARGEMENT OF A LEFT CEREBRAL SUBDURAL HEMATOMA MEASURING 2.8 CM IN THICKNESS COMPARED TO THE CT ON (B)(6) 2013. A 12 MM OF RIGHTWARD SUBFALCINE HERNIATION SECONDARY TO THE SUBDURAL HEMATOMA. THE SUBDURAL HEMATOMA WAS EVACUATED AND CT SHOWED PERSISTENCE OF THE CHRONIC SUBDURAL HEMATOMA SO A CRANIOTOMY WAS PERFORMED. A CT ON (B)(6) 2013, REVEALED INCREASED MASS EFFECT AND LEFT-TO-RIGHT MIDLINE SHIFT NOW MEASURING 9 MM COMPARED TO 4-5 MM PREVIOUSLY. THE PATIENT SHOWED NO EVIDENCE OF MEANINGFUL RECOVERY AND WAS DISCHARGED TO HOSPICE CARE ON (B)(6) 2013 AND THEN TO INPATIENT HOSPICE ON (B)(6) 2013. IT WAS LATER REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2013. THE EVENT WAS NOTED AS PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198713 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77500-16 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death