BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 6168971 · Received December 13, 2016

    Report

    Report Number
    3002808486-2016-01489
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 13, 2016
    Report Date
    November 23, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002346755
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. H9)3005580113-12JUN2017-001-R. SUMMARY OF INVESTIGATIONAL FINDINGS: DISTAL GRAFT DEVELOPING A NEAR OCCLUSIVE THROMBOSIS AT ONE YEAR IS CONFIRMED. THE THROMBUS WAS SEPARATE FROM A SMALI AMOUNT OF THROMBUS GENERATED BY FABRIC REDUNDANCY BETWEEN THE SECOND AND THIRD MAINBODY STENTS, DUE TO MINIMALLY DECREASED TIP TO TIP STENT LENGTH. THE MOST LIKELY ROOT CAUSE OF DISTAL GRAFT THROMBUS FORMATION WAS THE DEVELOPMENT OF AN AORTIC RIDGE, CAUSED BY EXCESS AORTIC LENGTH THAT LIKELY CREATED A RIDGE AT THE DISTAL AORTIC END, CREATING ENOUGH FLOW DISTURBANCE TO STIMULATE THROMBUS FORMATION. THE ETIOLOGY OF THE PATIENT'S PARALYSIS WAS LIKELY THE RESULT OF SPINAL CORD ISCHEMIA MOST LIKELY CAUSED BY INTERCOSTAL ARTERY EMBOLIZATION. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. RECALL WAS INITIATED AS INDICATION FOR USE FOR BTAI HAS BEEN REMOVED FROM THE PRODUCT LABELING. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR DEVICE UNDER 510(K) P140016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR DEVICE UNDER 510(K) P140016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE STENT FAILED. OCCLUSION DUE TO THROMBOSIS. ANOTHER STENT WAS PLACED AND THE PATIENT IS OK NOW. "ON FOLLOW UP (B)(6) 2016 THROMBUS WAS SEEN IN THE GRAFT. ON (B)(6) 2016 PT CALLED AMBULANCE. THE GRAFT HAD FULLY OCCLUDED IN THE DISTAL PART. ANOTHER ZTA-P-22-105 (LOT E3376387) WAS IMPLANTED. IT SOLVED THE MAIN ISSUE. BUT THE LUMEN IS STILL NOT THE SAME CALIBER". PATIENT OUTCOME: THE PATIENT REQUIRED ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. "THE DR DISCUSSING TO EXPLANT THE GRAFTS OR TO PUT A PALMAZ STENT TO INCREASE THE RADIAL FORCE". ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED ADVERSE EFFECTS DUE TO THIS OCCURRENCE "HYPERTENSION, PARAPLEGIA".

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE STENT FAILED. OCCLUSION DUE TO THROMBOSIS. ANOTHER STENT WAS PLACED AND THE PATIENT IS OK NOW. "ON FOLLOW UP (B)(6) 2016 THROMBUS WAS SEEN IN THE GRAFT. ON (B)(6) 2016 PT CALLED AMBULANCE. THE GRAFT HAD FULLY OCCLUDED IN THE DISTAL PART. ANOTHER ZTA-P-22-105 (LOT E3376387) WAS IMPLANTED. IT SOLVED THE MAIN ISSUE. BUT THE LUMEN IS STILL NOT THE SAME CALIBER". ADDITIONAL INFORMATION RECEIVED ON 19DEC2016: PREVIOUS IMPLANT DATE ((B)(6) 2016) HAS BEEN INCORRECT. CORRECT IMPLANT DATE IS (B)(6) 2015. PATIENT OUTCOME: THE PATIENT REQUIRED ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. "THE DR DISCUSSING TO EXPLANT THE GRAFTS OR TO PUT A PALMAZ STENT TO INCREASE THE RADIAL FORCE". ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED ADVERSE EFFECTS DUE TO THIS OCCURRENCE "HYPERTENSION, PARAPLEGIA".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821751 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002346755

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Life Threatening| R