BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 7459059 · Received April 25, 2018

    Report

    Report Number
    2029214-2018-00346
    Event Type
    Injury
    Date Received
    April 25, 2018
    Date of Event
    September 20, 2010
    Report Date
    April 25, 2018
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED INFORMATION, THERE WAS NO REASONABLY SUGGESTION THAT A QUALITY DEFICIENCY OF THE PED OCCURRED. NEUROLOGICAL DETERIORATION AND STROKE ARE KNOWN INHERITED COMPLICATIONS THAT MAY HAVE BEEN CAUSED BY HEMODYNAMIC CHANGES INDUCED BY THE PROCEDURE. PER THE REPORTING AUTHOR/S: THE EVENTS MAY BE ATTRIBUTABLE TO THE COVERAGE OF REGIONAL LENTICULOSTRIATE BRANCHES WITH MULTIPLE PEDS AS WELL AS TECHNICAL COMPLEXITIES ENCOUNTERED DURING THE PLACEMENT OF TELESCOPING PEDS AND AN ANCHORING NEUROFORM STENT AS WELL AS THE SUBSEQUENT COILING OF THE GIANT (25 MM) ANEURYSM. THE EXACT CAUSED CANNOT BE DETERMINED AND REMAINS UNKNOWN. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PROCEDURE COMPLICATION AND PATIENT CONDITION RELATED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THROUGH LITERATURE REVIEW OF ¿THE PIPELINE EMBOLIZATION DEVICE FOR THE INTRACRANIAL TREATMENT OF ANEURYSMS TRIAL¿ (P.K. NELSON, P. LYLYK, I. SZIKORA, S.G. WETZEL, I. WANKE, D. FIORELLA). 31 PATIENTS WITH 31 ANEURYSMS WERE ENROLLED BETWEEN JANUARY AND MAY 2007. 25 PATIENTS WERE WOMEN. AVERAGE AGE WAS 54.6 YEARS (RANGE, 35¿76 YEARS). IN THE ONE UNSUCCESSFUL PED PLACEMENT, THERE WAS DIMINISHED FLOW IN THE PARENT INTERNAL CAROTID ARTERY (ICA) FOLLOWING DEPLOYMENT OF THE PED AND COILING OF THE REMNANT ANEURYSM SAC. DURING ANGIOPLASTY PERFORMED TO CORRECT THE ATTENUATED FLOW, THE ICA BEYOND THE IMPLANT WAS RUPTURED. THE INDWELLING PED AND ANEURYSM COILS WERE REMOVED DURING AN ATTEMPTED SURGICAL REPAIR OF THE RUPTURED ARTERY, AND THE CAROTID ARTERY WAS ULTIMATELY LIGATED. TWO PATIENTS HAD MAJOR STROKE. THE PATIENT WITH IATROGENIC RUPTURE OF THE DISTAL ICA HAD A LARGE LEFT-HEMISPHERE STROKE. A SECOND PATIENT EXPERIENCED A PERIPROCEDURAL STROKE MANIFEST AS RIGHT-SIDED HEMIPARESIS AND MOTOR APHASIA FOLLOWING RECONSTRUCTION OF THE M1 SEGMENT OF THE LEFT MCA WITH 2 OVERLAPPING PEDS AND A NEUROFORM STENT FOLLOWED BY COIL EMBOLIZATION OF A GIANT M1 ANEURYSM. CT IMAGING 2 DAYS AFTER THE PROCEDURE SHOWED A LEFT DEEP GRAY MATTER INFARCTION. SPEECH FUNCTION IMPROVED SIGNIFICANTLY DURING THE PERIPROCEDURAL HOSPITALIZATION WITH MARKED ADDITIONAL IMPROVEMENT OBSERVED AT THE 30-DAY POSTPROCEDURAL VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304707 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention