BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4251425 · Received November 14, 2014

    Report

    Report Number
    2029214-2014-00650
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    October 15, 2014
    Manufacturer
    COVIDIEN
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT.THE OTHER DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS:MODEL#: NOT REPORTED / LOT#: NOT REPORTED / DOM: N/A / EXP: N/A (QTY. 2).(B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ARTICLE, FISCHER S, PEREZ MA, KURRE W, ET AL. PIPELINE EMBOLIZATION DEVICE FOR THE TREATMENT OF INTRA- AND EXTRACRANIAL FUSIFORM AND DISSECTING ANEURYSMS: INITIAL EXPERIENCE AND LONG-TERM FOLLOW-UP. NEUROSURGERY. 2014 OCT; 75(4):364-374. A TOTAL OF 65 PATIENTS (41 FEMALES AND 31 MALES) WITH 69 FUSIFORM OR DISSECTING ANEURYSMS (38 LOCATED IN THE POSTERIOR CIRCULATION AND 31 LOCATED IN THE ANTERIOR CIRCULATION) UNDERWENT ENDOVASCULAR PED (PIPELINE EMBOLIZATION DEVICE) TREATMENT. SIX CASES EXPERIENCED PED DEPLOYMENT DIFFICULTY. CASE# 6: TREATMENT OF A BA (BASILAR ARTERY) TRUNK ANEURYSM. THE PATIENT PRESENTED WITH MASS EFFECT AND EMBOLI. THE MRS (MODIFIED RANKIN SCALE) = 1. THE PATIENT UNDERWENT PED TREATMENT INVOLVING THREE PIPELINES. DURING THE PROCEDURE, THERE WAS A TWIST IN THE LAST PED AND IT DID NOT COMPLETELY OPEN AFTER COAXIAL IMPLANTATION OF THE THREE DEVICES. THE PED FINALLY OPENED WITH A BALLOON-EXPANDABLE CORONARY STENT (COROFLEX PLEASE). THERE WAS NO CLINICAL IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736504 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT COVIDIEN NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention