BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 6947202 · Received October 13, 2017

    Report

    Report Number
    3002808486-2017-01970
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    June 13, 2017
    Report Date
    January 3, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002347011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SIMILAR TO DEVICE UNDER 510(K) P140016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO STUDY: AT TIME OF ENROLLMENT THE PATIENT PRESENTED WITH A THORACIC AORTIC ANEURYSM >= 6 CM. ON (B)(6) 2017 (85 DAYS PRE-PROCEDURE), THE PRE-PROCEDURE IMAGING WAS PERFORMED. IT SHOWED NO CIRCUMFERENTIAL CALCIFICATIONS OF MAIN ACCESS VESSEL AND NO VESSEL WALL THROMBOSIS IN AORTIC NECKS > 50% OF CIRCUMFERENCE WAS OBSERVED. THE MAXIMUM ANEURYSM DIAMETER WAS 63 MM. THE PROXIMAL NECK DIAMETER WAS 32 MM. THE PROXIMAL NECK LENGTH WAS 107 MM. THE DISTAL NECK DIAMETER WAS 30 MM. THE DISTAL NECK LENGTH WAS 20 MM. ON (B)(6) 2017 THE PATIENT UNDERWENT SURGERY DUE TO HIS THORACIC AORTIC ANEURYSM. FOLLOWING COMPONENT WAS IMPLANTED SUCCESSFULLY DURING THE INDEX PROCEDURE: ONE PROXIMAL COMPONENT (CATALOG # ZTA-P-36-209, LOT # E3583483). LSA WAS NOT COVERED BY THE STENT GRAFT FABRIC AND THE PROXIMAL ZONE OF STENT GRAFT IMPLANTATION WAS ZONE 4. FOLLOWING ADDITIONAL PROCEDURES WAS PERFORMED DURING INDEX PROCEDURE: SPLENIC ARTERY EMBOLIZATION. PATIENT OUTCOME: IMMEDIATE POST-PROCEDURE, THE PATIENT WAS IN A STATE OF COMA AND SUFFERED FROM RENAL INSUFFICIENCY. IN RELATION TO THAT, THE SITE HAS REPORTED AN ADVERSE EVENT FOR PARAPLEGIA. THE PATIENT REMAINS IN THE STUDY.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016032. (B)(4). NAME AND ADDRESS FOR IMPORTER SITE: (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THIS COMPLAINT CONCERNS A PATIENT TREATED FOR A THORACIC AORTIC ANEURYSM. POST-PROCEDURE PARAPLEGIA WAS REPORTED. HOWEVER, NO INFORMATION REGARDING PATIENT OUTCOME WAS PROVIDED. AS PER IFU PARAPLEGIA IS A KNOWN POTENTIAL ADVERSE EVENT WHERE GRAFT EXCLUSION COVERS THE ORIGINS OF DOMINANT SPINAL CORD OR INTERCOSTAL ARTERIES. IT CAN NOT BE EXCLUDED THAT THE SPLENIC ARTERY EMBOLIZATION PLAYED A ROLE IN THE DEVELOPMENT OF THE PARAPLEGIA. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED 13DEC2017: THE TREATMENT FOR THIS PATIENT WAS "SPINAL CORDISCHEMIA PROTOCOL - CEREBROSPINAL FLUID DRAINAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728282 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002347011

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening