BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 6757491 · Received August 1, 2017

    Report

    Report Number
    2029214-2017-00928
    Event Type
    Injury
    Date Received
    August 1, 2017
    Date of Event
    March 6, 2017
    Report Date
    July 25, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SRINIVASAN, V. M., MOKIN, M., DUCKWORTH, E. A., CHEN, S., PURI, A., <(>&<)> KAN, P. (2017). TOURNIQUET PARENT ARTERY OCCLUSION AFTER FLOW DIVERSION. JOURNAL OF NEUROINTERVENTIONAL SURGERY. DOI:10.1136/NEURINTSURG-2016-012937. THE PIPELINE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY REMAIN IMPLANTED IN THE PATIENTS. BASED ON THE INFORMATION PROVIDED IN THE ARTICLES, THERE DOES NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICES DURING USE. THE EVENTS OCCURRED IN THE PATIENTS POST-PROCEDURE AND THE CAUSES COULD NOT BE CONCLUSIVELY DETERMINED FROM THE PROVIDED INFORMATION. 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 · 1

    MEDTRONIC LITERATURE REVIEW FOUND REPORTS OF THROMBOSIS AND IN-STENT STENOSIS IN ASSOCIATION WITH PIPELINE IMPLANTATION. THE PURPOSE OF THIS ARTICLE WAS TO REVIEW PATIENTS WHO EXPERIENCED PROGRESSIVE, ASYMPTOMATIC OCCLUSION OF THE PARENT ARTERY OCCLUSION AFTER PED IMPLANTATION. THE AUTHORS RETROSPECTIVELY REVIEWED 326 PATIENTS WHO WERE TREATED WITH THE PIPELINE EMBOLIZATION DEVICE (PED). THE ARTICLE STATES THAT ONE PATIENT EXPERIENCED ACUTE THROMBOSIS OF THE PED INTRAPROCEDURALLY WHICH RESULTED IN A MINOR STROKE. THE AUTHORS IDENTIFIED THREE PATIENTS WHO EXPERIENCED GRADUAL PARENT ARTERY OCCLUSION AFTER PIPELINE IMPLANTATION: - IN CASE 1, A PATIENT (MIDDLE-AGED, FEMALE) WAS INCIDENTALLY FOUND TO HAVE A WIDE-NECKED RIGHT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM DURING AN INVESTIGATION FOR RIGHT BASAL GANGLIA STROKE. THE PATIENT UNDERWENT PED PLACEMENT FROM THE PROXIMAL MCA TO THE M2 SEGMENT. SIX MONTHS POST-PROCEDURE, THE PATIENT HAD PERSISTENT MILD LEFT ARM WEAKNESS SECONDARY TO THE INITIAL STROKE AND NO NEW SYMPTOMS. CLOPIDOGREL WAS DISCONTINUED. AT THAT TIME, THE ANEURYSM WAS FULLY OBLITERATED WITH PRESERVATION OF THE PARENT VESSEL. FOURTEEN MONTHS POST-PROCEDURE, ANGIOGRAPHY SHOWED INTERVAL OCCLUSION OF THE RIGHT MCA DUE TO STENOSIS (>50%). THE PATIENT HAD COLLATERAL FLOW DUE TO DEVELOPMENT OF PIAL COLLATERALS WITH THE ANTERIOR CEREBRAL ARTERY (ACA). - IN CASE 2, A PATIENT (MIDDLE AGED, MALE) WAS INCIDENTALLY FOUND TO HAVE A P2 POSTERIOR CEREBRAL ARTERY (PCA) ANEURYSM DURING INVESTIGATION FOR A HEADACHE. THE PATIENT WAS TREATED ELECTIVELY WITH THREE OVERLAPPING PEDS PLACED ACROSS THE GIANT, PARTIALLY THROMBOSED, FUSIFORM DISSECTING PCA ANEURYSM, WHICH INCLUDED A FOCAL STENOSIS JUST PROXIMAL TO THE FUSIFORM SEGMENT. CONE-BEAM CT CONFIRMED SATISFACTORY WALL APPOSITION AND EARLY STASIS WITHIN THE ANEURYSM. THREE MONTHS POST-PROCEDURE, FOLLOW-UP ANGIOGRAPHY SHOWED SEVERE STENOSIS WHERE THE PEDS OVERLAPPED. THE PATIENT REMAINED NEUROLOGICALLY ASYMPTOMATIC. SIX MONTHS POST-PROCEDURE, FOLLOW-UP ARTERIOGRAM SHOWED COMPLETE IN-STENT OCCLUSION (>50% STENOSIS). SEVERAL AREAS OF MCA¿PCA PIAL COLLATERALS WERE OBSERVED. ONE YEAR POST-PROCEDURE, THE PATIENT SHOWED IMPROVEMENT OF THE STENOSIS WITH RESTORATION OF NORMAL FLOW INTO THE MCA AND ACA. AS OF 16 MONTHS POST-PROCEDURE, THE PATIENT HAD NO NEUROLOGICAL SEQUELAE. - IN CASE 3, A PATIENT (ELDERLY, FEMALE) WAS INCIDENTALLY FOUND TO HAVE AN A2 ACA ANEURYSM DURING INVESTIGATION OF A MINOR HEAD TRAUMA. THE PATIENT WAS TREATED ELECTIVELY WITH THE PLACEMENT OF A SINGLE PED. THREE MONTHS POST-PROCEDURE, FOLLOW-UP ANGIOGRAM REVEALED GOOD FLOW THROUGH THE PED WITH NO IN-STENT STENOSIS AND STASIS BUT PERSISTENT FILLING WITHIN THE ANEURYSM. SIX MONTHS POST-PROCEDURE, THE PATIENT WAS NOTED TO HAVE AN OCCLUSION OF THE ACA FROM THROMBOSIS OF THE DEVICE WITHOUT ANY NEUROLOGICAL SEQUELAE. MCA¿ACA PIAL COLLATERALS HAD DEVELOPED IN THE INTERVAL. ALL THREE OF THESE PATIENTS WERE ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537879 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other