BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 5350177 · Received January 7, 2016

    Report

    Report Number
    1820334-2016-00012
    Event Type
    Injury
    Date Received
    January 7, 2016
    Date of Event
    December 4, 2015
    Report Date
    May 17, 2017
    Manufacturer
    COOK INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT IS STILL UNDER INVESTIGATION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    EVALUATION: A DOCUMENT BASED INVESTIGATION EVALUATION WAS ALSO PERFORMED. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, SPECIFICATIONS AND TRENDS WAS CONDUCTED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE, LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. PER THE IFU "VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ENDOVASCULAR GRAFT AND/OR MAY INCREASE THE RISK OF EMBOLIZATION. PRE-EXISTING REGIONS OF STENOSIS/NARROWING HAVE BEEN SHOWN TO INCREASE THE RISK OF A THROMBOEMBOLIC EVENT. FOLLOW-UP IMAGING SHOULD BE CAREFULLY REVIEWED FOR NARROWING WITHIN THE GRAFT LEG. PATIENTS WITH A GRAFT LEG LUMEN OF LESS THAN APPROXIMATELY 5MM ID MAY BE AT INCREASED RISK OF A THROMBOEMBOLIC EVENT. PATIENTS WITH POOR OUTFLOW OR A HYPERCOAGULABLE STATE MAY BE AT AN INCREASED RISK OF A THROMBOEMBOLIC EVENT. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ARTERIAL OR VENOUS THROMBOSIS." PATIENT SELECTION, TREATMENT AND FOLLOW-UP: "ZENITH (B)(6) ILIAC ARTERY DISTAL FIXATION SITE GREATER THAN 10 MM IN LENGTH AND 7.5 - 20 MM IN DIAMETER (MEASURED OUTER WALL TO OUTER WALL) IS REQUIRED. THESE SIZING MEASUREMENTS ARE CRITICAL TO THE PERFORMANCE OF THE ENDOVASCULAR REPAIR." "PATIENTS WITH POOR OUTFLOW OR A HYPERCOAGULABLE STATE (E.G., CANCER) MAY BE AT AN INCREASED RISK OF A THROMBOEMBOLIC EVENT." DEVICE DIAMETER SIZING GUIDELINES: "THE CHOICE OF DIAMETER SHOULD BE DETERMINED FROM THE OUTER WALL TO OUTER WALL VESSEL DIAMETER AND NOT THE LUMEN DIAMETER. UNDERSIZING OR OVERSIZING MAY RESULT IN INCOMPLETE SEALING OR COMPROMISED FLOW." FOR THE ILIAC LEG DIAMETER SELECTED (16 MM), THE INTENDED ILIAC VESSEL DIAMETER IS 13 TO 15 MM. BASED ON THE INFORMATION PROVIDED IN THE COMPLAINT REPORT AND THE IMAGE REVIEW, THE ROOT CAUSE OF THE THROMBUS MAY BE RELATED TO THE "PROCEDURE AND PATIENT CONDITION RELATED TO THE OCCURRENCE" DUE TO THE PATIENT ANATOMY AN HIS PRE-EXISTING CONDITIONS.

    Description of Event or Problem · 1

    THIS (B)(6) PATIENT IN THE ZENITH ILIAC BRANCH SYSTEM CLINICAL STUDY WAS NOTED TO HAVE THROMBOSIS IN THE RIGHT EXTERNAL ILIAC LEG GRAFT (SAME SIDE AS THE BRANCH GRAFT) 25 DAYS POST-PROCEDURE. INDEX PROCEDURE: ON (B)(6) 2015, THE PATIENT UNDERWENT AN EVAR PROCEDURE. THERE WAS NO DIFFICULTY DEPLOYING ANY OF THE DEVICES. NO ADDITIONAL PROCEDURES WERE PERFORMED. A MOLDING BALLOON WAS USED WITHOUT DIFFICULTY. POST STENT DILATATION WAS NOT PERFORMED. POST-PROCEDURE ANGIOGRAPHY REVEALED PATENT DEVICES WITH NO ENDOLEAKS OR KINKS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015 (2 DAYS PP). ON (B)(6) 2015 (25 DAYS PP), THE PATIENT WAS FOUND TO HAVE A THROMBOSIS IN THE RIGHT EXTERNAL ILIAC ARTERY (SAME SIDE AS THE BRANCH GRAFT). ON (B)(6) 2015 (32 DAYS PP), THE PATIENT WAS TREATED WITH BALLOON ANGIOPLASTY AND THROMBECTOMY. FOLLOWING THE SECONDARY INTERVENTION, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015 (35 DAYS PP). NO OTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11371 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention