BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4818346 · Received June 4, 2015

    Report

    Report Number
    2029214-2015-00627
    Event Type
    Injury
    Date Received
    June 4, 2015
    Date of Event
    February 1, 2015
    Report Date
    May 11, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE WEBSITE: HTTP://INE.SAGEPUB.COM/CONTENT/21/1/6.LONG. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS NOT REPORTED. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENTS. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECTS OF THE DEVICES DURING USE. THE EVENTS OCCURRED IN THE PATIENTS POST PROCEDURE AND THEIR CAUSES WERE UNKNOWN. THE AUTHORS STATED, "WHILE WE INTENTIONALLY EXCLUDED COMPLICATIONS THAT WERE PRESENT ON ADMISSION TO ONLY EXAMINE COMPLICATIONS THAT OCCURRED DURING HOSPITALIZATION, IT IS POSSIBLE THAT SOME COMPLICATIONS WERE CODED INCORRECTLY OR OCCURRED INDEPENDENTLY OF FLOW DIVERSION TREATMENT." THERE IS LIMITED INFORMATION ABOUT THE DEVICE AND/OR THE PATIENT, THEREFORE ALL SERIOUS ADVERSE EVENTS WERE CAPTURED IN THIS REPORT. THIS PREMIER PERSPECTIVE DATABASE OF MULTIPLE HOSPITALS IN THE UNITED STATES DID NOT INCLUDE DETAILED PATIENT INFORMATION INCLUDING INTRACRANIAL ANEURYSM SIZE AND LOCATION. NO MORE INFORMATION WILL BE AVAILABLE SINCE NO FURTHER FOLLOW UP ATTEMPTS CAN BE MADE. SAME ARTICLE AS REPORTED IN MDR#2029214-2015-00629.

    Description of Event or Problem · 1

    MEDTRONIC (B)(4) RECEIVED THIS INFORMATION THROUGH LITERATURE REVIEW: THE AUTHORS EVALUATED A NATIONAL, MULTIHOSPITAL PATIENT DATABASE TO EXAMINE PERIPROCEDURAL MORBIDITY AND MORTALITY IN PATIENTS TREATED WITH ENDOVASCULAR FLOW DIVERSION THERAPY. THE PREMIER PERSPECTIVE DATABASE WAS USED TO IDENTIFY PATIENTS HOSPITALIZED BETWEEN MAY 2011 AND MARCH 2013 FOR UNRUPTURED ANEURYSM WHO UNDERWENT FLOW DIVERSION THERAPY WITH A PIPELINE EMBOLIZATION DEVICE. THE RISK OF IN-HOSPITAL MORTALITY AND MORBIDITY WAS DETERMINED USING ICD 9 CODES. A TOTAL OF 279 UNRUPTURED ANEURYSM PATIENTS AT 18 MEDICAL CENTERS UNDERWENT ENDOVASCULAR THERAPY WITH PIPELINE DEVICES. ADVERSE OUTCOMES INCLUDED ISCHEMIC COMPLICATIONS IN 14 CASES (5.0%), HEMORRHAGIC COMPLICATIONS IN FOUR CASES (1.4%), AND POSTOPERATIVE NEUROLOGICAL COMPLICATIONS IN NINE CASES (3.2%). IN HOSPITAL MORTALITY IS REPORTED IN MDR#2029214-2015-00629. PATIENTS WHO RECEIVED A PIPELINE DEVICE WERE TYPICALLY MIDDLE-AGED FEMALES (MEDIAN AGE: 58 YRS.; FEMALE GENDER: 70%; 195/279) WHO WERE TREATED ELECTIVELY (70% OF CASES; 195/279). THE MAJORITY OF HOSPITALS THAT PERFORMED A PIPELINE PROCEDURE WERE LOCATED IN THE NORTHEAST (90%; 250/279) IN URBAN LOCATIONS (99%; 278/279) AND WERE CLASSIFIED AS TEACHING HOSPITALS (98%; 273/279). CITATION: MCDONALD RJ, MCDONALD JS, KALLMES DF, ET AL. PERIPROCEDURAL SAFETY OF PIPELINE THERAPY FOR UNRUPTURED CEREBRAL ANEURYSMS: ANALYSIS OF 279 PATIENTS IN A MULTIHOSPITAL DATABASE. INTERV NEURORADIOL. 2015 FEB;21(1):6-10. (HTTP://INE.SAGEPUB.COM/CONTENT/21/1/6.LONG).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362944 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Disability