BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 6448701 · Received March 30, 2017

    Report

    Report Number
    2029214-2017-00304
    Event Type
    Injury
    Date Received
    March 30, 2017
    Date of Event
    January 6, 2017
    Report Date
    March 3, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: MATTHEW B. POTTS, MD, MAKSIM SHAPIRO, MD, DANIEL W. ZUMOFEN, MD, EYTAN RAZ, MD, EREZ NOSSEK, MD, KEITH G. DESOUSA, MD, TIBOR BECSKE, MD, HOWARD A. RIINA, MD, AND PETER K. NELSON, MD. PARENT VESSEL OCCLUSION AFTER PIPELINE EMBOLIZATION OF CEREBRAL ANEURYSMS OF THE ANTERIOR CIRCULATION. J NEUROSURG JANUARY 6, 2017 THE DEVICE WAS NOT RETURNED AS IT WAS IMPLANTED IN THE PATIENT; THEREFORE, PRODUCT ANALYSIS OF THE PIPELINE DEVICES WAS NOT ABLE TO BE PERFORMED. THE MODEL AND LOT NUMBERS OF THE PIPELINE EMBOLIZATION DEVICES IMPLANTED WERE NOT REPORTED IN THE ARTICLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE MAIN AUTHOR OF THIS ARTICLE, HOWEVER NO FURTHER INFORMATION HAS BEEN PROVIDED. SHOULD THE REQUESTED INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE AUTHORS PERFORMED A RETROSPECTIVE REVIEW OF ALL ANTERIOR CIRCULATION ANEURYSMS CONSECUTIVELY TREATED AT A SINGLE INSTITUTION WITH THE PED THROUGH 2014, IDENTIFYING THOSE WITH PVO ON FOLLOW-UP IMAGING. THE CAUSES OF PVO IN THIS SERIES WERE NOT CONFIDENTLY IDENTIFIED BY THE AUTHORS. THE AUTHORS NOTE THAT THE CASES OF DELAYED PVO IN THE LITERATURE HAVE BEEN REPORTED TO OCCUR SOON AFTER DISCONTINUATION OF CLOPIDOGREL, EITHER AS PRESCRIBED BY THE TREATING PHYSICIANS BASED ON MEDICAL NECESSITY OR FOLLOW-UP IMAGING 6,9,13 OR WHEN SELF-DISCONTINUED BY PATIENT. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. AFTER REVIEWING THE IFU, AND REVIEW OF LITERATURE TO INVESTIGATE THE COMPLAINT, THE MOST LIKELY CAUSE FOR THE COMPLAINT IS RELATED TO THE PATIENT CONDITION. REFERENCE MDRS 2029214-2017-00304, 2029214-2017-00305, 2029214-2017-00306, 2029214-2017-00307 FOR THIS SUBJECT. OTHER MDRS FROM THIS LITERATURE REVIEW: 2029214-2017-00295, 2029214-2017-00296, 2029214-2017-00297, 2029214-2017-00298, 2029214-2017-00299 2029214-2017-00300, 2029214-2017-00301, 2029214-2017-00302, 2029214-2017-00303, 2029214-2017-00308, 2029214-2017-00309, 2029214-2017 -00310, 2029214-2017-00311, 2029214-2017-00312, 2029214-2017-00313 2029214-2017-00314, 2029214-2017-00315, 2029214-2017-00316, 2029214-2017-00317, 2029214-2017-00318, 2029214-2017-00319, 2029214-2017 -00320, 2029214-2017-00321, 2029214-2017-00322, 2029214-2017-00323 2029214-2017-00324, 2029214-2017-00325, 2029214-2017-00326, 2029214-2017-00327, 2029214-2017-00328, 2029214-2017-00329. 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 INFORMATION THROUGH LITERATURE REVIEW THAT THIS PATIENT EXPERIENCED ASYMPTOMATIC PARENT VESSEL OCCLUSION (PVO) AFTER PIPELINE EMBOLIZATION PROCEDURE. THE PVO WAS DISCOVERED ON ROUTINE FOLLOW-UP IMAGING AT 6 MONTHS. THERE WAS NO NEW PERMANENT NEUROLOGICAL DEFICIT AND THE GOAL OF COMPLETE ANEURYSM OCCLUSION WAS ACHIEVED. THERE WAS COLLATERAL SUPPLY TO THE OCCLUDED ICA TERRITORY THROUGH THE CIRCLE OF WILLIS¿VIA THE ANTERIOR COMMUNICATING ARTERY AND THE IPSILATERAL POSTERIOR COMMUNICATING ARTERY. THIS (B)(6) PATIENT PRESENTED WITH CRANIAL NERVE VI PALSY AND WAS FOUND TO HAVE A CAVERNOUS ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA) MEASURING 28.1MM WITH A NECK WIDTH OF 8.5MM. SEGMENTAL STENOSIS OF THE ICA BOTH PROXIMAL AND DISTAL TO THE ANEURYSM WAS TREATED WITH BALLOON ANGIOPLASTY PRIOR TO DEPLOYMENT OF THE PED CONSTRUCT. THE PATIENT WAS TREATED WITH 4 PIPELINE EMBOLIZATION DEVICES. THIS PATIENT RECEIVED CLOPIDOGREL, 75 MG DAILY, FOR 7 DAYS PRIOR TO EMBOLIZATION AND ASPIRIN, 325 MG DAILY, FOR 2 DAYS PRIOR TO EMBOLIZATION WITHOUT PRE- OR POST-PROCEDURAL PLATELET FUNCTION TESTING. THIS PROCEDURE WAS PERFORMED PRIOR TO P2Y12 PLATELET FUNCTIONAL TESTING BECAME AVAILABLE. UPON DISCHARGE THE PATIENT WAS PRESCRIBED A MINIMUM OF 6 MONTHS OF DUAL ANTIPLATELET THERAPY (DAPT) WITH ASPIRIN AND CLOPIDOGREL. THE DECISION TO STOP OR EXTEND THE COVERAGE WAS SUBSEQUENTLY BASED ON THE RESULTS OF FOLLOW UP ANGIO. AT THE ROUTINE 6 MONTH FOLLOW UP A COMPLETE OCCLUSION OF THE PARENT VESSEL WAS OBSERVED. AT THE 3 YEAR IMAGING FOLLOW UP BOTH THE ANEURYSM AND PARENT VESSEL REMAINED OCCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230579 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other