BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4406088 · Received January 9, 2015

    Report

    Report Number
    2029214-2015-00026
    Event Type
    Injury
    Date Received
    January 9, 2015
    Report Date
    December 12, 2014
    Manufacturer
    COVIDIEN
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBERS WERE NOT REPORTED. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE IMPLANTED IN THE PATIENT; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. THE OTHER DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS: MODEL#: NOT REPORTED / LOT#: NOT REPORTED / DOM: N/A / EXP: N/A (QTY UNKNOWN) (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ARTICLE: MOON K, ALBUQUERQUE FC, DUCRUET AF, ET AL. RESOLUTION OF CRANIAL NEUROPATHIES FOLLOWING TREATMENT OF INTRACRANIAL ANEURYSMS WITH THE PIPELINE EMBOLIZATION DEVICE. J NEUROSURG. 2014; 121:1085¿1092. A TOTAL OF 127 PATIENTS WERE TREATED WITH THE PIPELINE EMBOLIZATION DEVICE AT THE AUTHORS¿ INSTITUTION AFTER FDA APPROVAL. TWENTY-TWO PATIENTS PRESENTED WITH CRANIAL NEUROPATHIES, FOR INITIAL INCLUSION IN THIS STUDY. OF THESE, 20 HAD SUFFICIENT FOLLOW-UP FOR ANALYSIS. CRANIAL NEUROPATHIES INCLUDED THOSE OF CN II, III, V, AND VI, WITH PRESENTING SYMPTOMS OF DIPLOPIA, DECREASED VISUAL ACUITY, AND FACIAL NUMBNESS AND/OR PAIN. THIRTEEN LESIONS WERE CAVERNOUS SEGMENT ICA ANEURYSMS, WHEREAS THE REMAINDER INCLUDED SUPRACLINOID AND PETROUS SEGMENT ICA, POSTERIOR COMMUNICATING ARTERY, AND BASILAR TRUNK ANEURYSMS. AT AN AVERAGE CLINICAL FOLLOW-UP OF 9.55 MONTHS, 15 PATIENTS HAD RESOLUTION OR SIGNIFICANT IMPROVEMENT OF THEIR CRANIAL NEUROPATHIES, AND THE REMAINING 5 HAD STABLE SYMPTOMS. OF THE 18 PATIENTS WITH ANGIOGRAPHIC FOLLOW-UP, 12 DEMONSTRATED COMPLETE OBLITERATION OR SMALL NECK RESIDUAL, WHEREAS 6 HAD RESIDUAL LESION. PATIENTS WITH COMPLETE OR NEAR-COMPLETE OBLITERATION OF THEIR LESION WERE SIGNIFICANTLY MORE LIKELY TO DEMONSTRATE SYMPTOMATIC IMPROVEMENT AT FOLLOW-UP. TWO PATIENTS WITH PERSISTENT SYMPTOMS WERE EVENTUALLY TREATED WITH MICROSURGICAL BYPASS. TRANSIENT COMPLICATIONS IN THIS SERIES INCLUDED 6 EXTRACRANIAL HEMORRHAGIC COMPLICATIONS RELATED TO DUAL-ANTIPLATELET THERAPY, ALL OF WHICH WERE MANAGED MEDICALLY. THERE WAS 1 DELAYED RIGHT ICA OCCLUSION FOLLOWING RETREATMENT THAT LED TO MICROSURGICAL BYPASS. THE PATIENT WAS DIAGNOSED WITH A GIANT ANEURYSM MEASURING APPROXIMATELY 40MM LOCATED IN THE CAVERNOUS SEGMENT OF THE ICA (INTERNAL CAROTID ARTERY) AND CRANIAL NERVE (CN) PALSY OF CN V AND CNVI, BRANCHES V1 AND V2 WITH NUMBNESS. THE PATIENT WAS INITIALLY TREATED WITH DEPLOYMENT OF 2 PIPELINES (SIZES NOT DISCLOSED) FOR THE ANEURYSM. THE PATIENT'S ANEURYSM IMPROVED WITH SOME RESIDUAL FILLING AND ALSO CONTINUED TO SUFFER FROM MILDER CRANIAL NEUROPATHIC ADVERSE EVENTS SUCH RELATED TO CNS V AND VI. COMPLICATIONS INCLUDED ALOPECIA AFTER 1ST TREATMENT, AND DELAYED RIGHT ICA OCCLUSION FOLLOWING RETREATMENT PERFORMED AT 6 MONTHS THAT LEAD TO MICROSURGICAL BYPASS SURGERY DOCUMENTED AT 9 MONTH FOLLOW-UP. LATER ON, THE PATIENT DEMONSTRATED A SYMPTOMATIC PERFUSION DEFICIT AND UNDERWENT AN OCCIPITAL ARTERY MIDDLE CEREBRAL ARTERY (MCA) BYPASS, RESULTING IN IMMEDIATE IMPROVEMENT OF HIS HEMIPARESIS, AS WELL AS DELAYED RESOLUTION OF HIS CRANIAL NEUROPATHIES. INFORMATION RECEIVED FROM THE SAME ARTICLE AS MDR# 2029214-2015-00025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22482 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention| S