BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 6448737 · Received March 31, 2017

    Report

    Report Number
    2029214-2017-00322
    Event Type
    Injury
    Date Received
    March 31, 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 2029214-2017-00321, 2029214-2017-00322 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, 2029214-2017-00304, 2029214-2017-00305, 2029214-2017 -00306, 2029214-2017-00307, 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, 2029214-2017-00323, 2029214-2017-00324, 2029214-2017-00325, 2029214-2017-00326, 2029214-2017-00327, 2029214-2017 -00328, 2029214-2017-00329.

    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 18 MONTHS. THERE WAS NO NEW PERMANENT NEUROLOGICAL DEFICIT AND THE GOAL OF COMPLETE ANEURYSM OCCLUSION WAS ACHIEVED. THERE WAS COLLATERAL SUPPORT THROUGH THE EXTERNAL CAROTID ARTERY RECONSTITUTION OF THE IPSILATERAL OPHTHALMIC ARTERY. THIS (B)(6) FEMALE PATIENT PRESENTED WITH A HEADACHE AND WAS FOUND TO HAVE AN ANEURYSM IN THE LEFT PARAOPHTHALMIC ARTERY MEASURING 12.5MM WITH A NECK WIDTH OF 10MM. THE PATIENT WAS TREATED WITH 2 PIPELINE. PRIOR TO THE EMBOLIZATION PROCEDURE THE PATIENT HAD A P2Y12 LEVEL OF 242 PRU AND WAS GIVEN ABCIXIMAB INTRAARTERIALLY DURING THE EMBOLIZATION PROCEDURE. SUBSEQUENT P2Y12 LEVELS WERE 291, 254, AND 154 PRU ON POST EMBOLIZATION DAS 1, 2, AND 3, RESPECTIVELY. THE PATIENT WAS ALSO GIVEN ASPIRIN 300MG THE EVENING OF THE PROCEDURE AND THEN ASPIRIN 325MG AND CLOPIDOGREL 150MG DAILY ON POSTEMBOLIZATION DAYS 1-3 UNTIL TESTING INDICATING SUITABLE P2Y12 INHIBITION. THE PATIENT WAS DISCHARGED ON A REGIMEN OF ASPIRIN 325MG AND CLOPIDOGREL 75MG DAILY FOR A MINIMUM OF 6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231673 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other