BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 4629651 · Received March 20, 2015

    Report

    Report Number
    1820334-2015-00163
    Event Type
    Injury
    Date Received
    March 20, 2015
    Date of Event
    October 20, 2014
    Report Date
    February 26, 2015
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    EVAL: FOR THIS EVENT, A REVIEW OF THE COMPLAINT HISTORY, INSTRUCTION FOR USE PAMPHLET (IFU), AND TRENDS WAS COMPLETED. THE DEVICE WAS NOT RETURNED NOR ANY IMAGES TO ASSIST WITH THIS INVESTIGATION BY THE REPORT 38 DAYS POST-PROCEDURE THE PATIENT EXPERIENCED CLINICAL SIGNS INDICATIVE OF CLAUDICATION. A DEFINITIVE ROOT CAUSE CAN NOT BE DETERMINED OR REPORTED AT THIS TIME. THIS PRODUCT LINE HAS ADDRESSED ALL DESIGN CONTROL REQUIREMENTS AND SHOWN THE DEVICE HAS MET THE PREDETERMINED REQUIREMENTS AND THAT THOSE REQUIREMENTS MEET THE NEEDS OF THE USER EACH DEVICE IS SENT WITH AN IFU, WHICH DESCRIBES THE INDICATIONS FOR USE, WARNINGS, PRECAUTIONS, AND THE PROPER DEPLOYMENT SEQUENCE ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO CLAUDICATION (E G , BUTTOCK, LOWER LIMB). THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATION. NOR IS THERE ANY EVIDENCE OF A DESIGN OR PROCESS INDUCED FAILURE TO RESPOND AFFIRMATIVELY. IT IS UNCLEAR WHERE THE CLAUDICATION OCCURRED OR IF IT WAS RELATED TO PRE-EXISTING ANATOMICAL CONDITIONS OR USE OF THE DEVICE. APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED, AND MONITORING FOR SIMILAR COMPLAINTS WILL CONTINUE.

    Description of Event or Problem · 1

    ON (B)(6) 2014 (27 DAYS POST-PROCEDURE) THE PATIENT WAS SEEN IN FOLLOW-UP. THERE HAD BEEN NO CHANGE IN THE SIZE OF THE ANEURYSM. DEVICES WERE PATENT WITH NO EXTERNAL COMPRESSION, FLOW-LIMITING KINKS, THROMBUS, ENDOLEAK OR MIGRATION. ON (B)(6) 2014 (38 DAYS POST-PROCEDURE) THE PATIENT EXPERIENCED CLAUDICATION (LOWER LIMB OR BUTTOCK). NO OTHER INFORMATION REGARDING THE EVENT IS AVAILABLE. NO OTHER FOLLOW UP VISITS WERE REPORTED.

    Description of Event or Problem · 1

    A (B)(6) MALE PT IN THE SPIRAL-Z POST-MARKET REGISTRY (11-015) EXPERIENCED CLAUDICATION ON (B)(6) 2014 (38 DAYS POST PROCEDURE). THE PT WAS TREATED ON (B)(6) 2014 FOR AN AORTIC ANEURYSM. THE MAXIMUN AORTIC DIAMETER WAS 53 MM. THE PROXIMAL NECK HAD A PARALLEL SHAPE WITH PARTIAL PLAQUE. THROMBUS. THE LEFT ILIAC ARTERY HAD MILD TORTUOSITY, NO OCCLUSIVE DISEASE, AND NO CALCIFICATION. THE RIGHT ILIAC ARTERY HAD NO TORTUOSITY, MILD OCCLUSIVE DISEASE, AND NO CALCIFICATION. THE PT REC'D A MAIN-BODY DEVICE, A LEFT ILIAC LEG, AND RIGHT ILIAC LEG. THERE WAS NO DIFFICULTY DEPLOYING ANY OF THE COMPONENTS. NO OTHER PROCEDURES WERE PERFORMED AND NO ADD'L DEVICES WERE USED. A MOLDING BALLOON WAS USED BY NO DETAILS WERE PROVIDED REGARDING ITS USE. AT THE CONCLUSION OF THE PROCEDURE, THE DEVICES WERE PT WITH NO EXTERNAL COMPRESSION, FLOW-LIMITING KINGS, OR THROMBUS. AN ENDOLEAK WAS NOTED, BUT NO SUB-TYPE WAS SPECIFIED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190395 UNK MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other