BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3984550 · Received August 6, 2014

    Report

    Report Number
    2029214-2014-00456
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    July 11, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT.(B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM AN ARTICLE: COLBY GP, LIN LM, GOMEZ JF, ET AL. IMMEDIATE PROCEDURAL OUTCOMES IN 35 CONSECUTIVE PIPELINE EMBOLIZATION CASES: A SINGLE-CENTER SINGLE USER EXPERIENCE. J NEUROINTERV SURG. 2013; 5:237-24, 34 PATIENTS (WITH A MEAN AGE RANGE OF 56.4 YRS) WITH 41 UNRUPTURED ANEURYSMS WERE TREATED WITH PED (PIPELINE EMBOLIZATION DEVICES). ALL THE PATIENTS PRESENTED WITH UNRUPTURED ANEURYSM/S AND SEVERE HEADACHE/S. ALL PATIENTS WERE PREOPERATIVELY TREATED WITH DUAL ANTI-PLATELET THERAPY THAT CONSISTED OF ASPIRIN AND CLOPIDOGREL 7 DAYS PRIOR TO THE PROCEDURE (27 FEMALES AND 7 MALES, AGE RANGE 23-78). FOUR OF THE CASES INVOLVED DEVICE MALFUNCTIONS. ONE CASE WAS ASSOCIATED WITH A SUBARACHNOID HEMORRHAGE LEADING TO THE PATIENT'S DEATH. ONE CASE HAD A REPORT OF IPSILATERAL LEG WEAKNESS CAUSED BY AN EMBOLIC EVENT. ONE CASE HAD A REPORT OF TRANSIENT NEUROLOGICAL DEFICIT POST PED PROCEDURE. A TOTAL OF 69 PEDS WERE USED IN 35 CASES (ONE PATIENT HAD 2 CASES). OUT OF THESE 35 CASES, FOUR CASES INVOLVED PIPELINES THAT HAD DIFFICULTY FULLY OPENING. THREE CASES REQUIRED RETRIEVAL OF THE PEDS AFTER FAILING TO OPEN PROPERLY. IN ONE OF THE THREE CASES IN WHICH THE PED WAS RETRIEVED FROM THE PATIENT AFTER NOT OPENING PROPERLY, THE PROCEDURE WAS ABORTED BECAUSE THE PATIENT HAD AN 8MM PARAOPHTHALMIC ANEURYSM WITH EXTREME TORTUOSITY OF THE SUPRACLINOID ICA (INTERNAL CAROTID ARTERY) AND THE M1 SEGMENT. FOR THE ONE CASE IN WHICH THE PIPELINE WAS NOT RETRIEVED FROM THE PATIENT, BALLOON ANGIOPLASTY (AN OPTION PRESENTED IN THE INSTRUCTIONS FOR USE, U.S.) WAS PERFORMED TO ACHIEVE FULL WALL APPOSITION. SAME EVENT AS MDR# 2029214-2014-00453 / 2029214-2014-00454 / 2029214-2014-00455.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460309 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention