BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4406087 · Received January 9, 2015

    Report

    Report Number
    2029214-2015-00025
    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 REVIEWS WERE 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#: FA-77450-20 / LOT#: NOT REPORTED / DOM: N/A / EXP: N/A; MODEL#: NOT REPORTED / LOT#: NOT REPORTED / DOM: N/A / EXP: N/A (QTY 4). (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. THE PATIENT PRESENTED WITH A 3-DAY HISTORY OF ACUTE-ONSET HEADACHE AND DOUBLE VISION. THE PATIENT WAS NOTED ON EXAMINATION TO HAVE LEFT-SIDED CN III AND VI PALSIES, AND IMAGING DEMONSTRATED A GIANT 30-MM CAVERNOUS SEGMENT ICA ANEURYSM. THE PATIENT WAS CONSIDERED FOR CLIP OCCLUSION WITH BYPASS GRAFTING, BUT PARENT VESSEL SACRIFICE WAS NOT INITIALLY DESIRABLE GIVEN HER YOUNG AGE. THE PATIENT UNDERWENT TREATMENT WITH 2 DEVICES MEASURING 4.5MM X 20 MM. SHORTLY AFTER THE INITIAL TREATMENT, THERE WAS A SIGNIFICANT LEFT-SIDED PROPTOSIS, WHICH RESOLVED OVER THE COURSE OF A FEW WEEKS. AS ASCERTAINED BY PHONE FOLLOW-UP AT 3 MONTHS, THE PATIENT HAD NEAR RESOLUTION OF VISUAL COMPLAINTS, WITH SOME MILD PERSISTENT DOUBLE VISION ON EXTREME RIGHT-SIDED LATERAL GAZE. HOWEVER, SHE STILL SUFFERED FROM CONSTANT DAILY HEADACHES. AN MRA (MAGNETIC RESONANCE ANGIOGRAPHY) STUDY OBTAINED AT 16 MONTHS DEMONSTRATED SOME RESIDUAL FILLING, AND THE PATIENT UNDERWENT FOLLOW-UP ANGIOGRAPHY AT 18 MONTHS, WHICH DEMONSTRATED SEPARATION OF THE OVERLAPPING CONSTRUCTS, WITH PROLAPSE INTO THE ANEURYSM DOME. THE PATIENT UNDERWENT PLACEMENT OF 2 ADDITIONAL DEVICES AT THIS TIME. DESPITE BEING INSTRUCTED TO DISCONTINUE HER CLOPIDOGREL AT 3 MONTHS FOLLOWING RETREATMENT AND CONTINUED TO DEMONSTRATE RESIDUAL ANEURYSM ON ANGIOGRAPHY, REQUIRING ADDITIONAL RETREATMENT WITH 2 DEVICES. AT 28 MONTHS FOLLOWING HER INITIAL TREATMENT, SHE UNDERWENT HER FINAL FOLLOW-UP ANGIOGRAM, WHICH DEMONSTRATED CONTINUED FILLING OF HER LESION. HER CLINICAL STATUS REMAINED STABLE, WITH ONLY MILD RESIDUAL DIPLOPIA, BUT BURDENSOME CHRONIC DAILY HEADACHES. SHE UNDERWENT MICROSURGICAL CLIP OCCLUSION OF HER LEFT ICA WITH A SUPERFICIAL TEMPORAL ARTERY (STA) MCA BYPASS, COMPLICATED BY TRANSIENT RIGHT-SIDED WEAKNESS AND SPEECH DIFFICULTY FOLLOWING SURGERY. HER HEADACHES IMPROVED DRAMATICALLY FOR SEVERAL MONTHS FOLLOWING SURGERY, BUT HAVE RETURNED TO A LESSER EXTENT AT LAST FOLLOW-UP 9 MONTHS POSTOPERATIVELY. INFORMATION RECEIVED FROM THE SAME ARTICLE AS MDR# 2029214-2015-00026

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21838 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN FA-77450-20 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention| S