BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 7493505 · Received May 8, 2018

    Report

    Report Number
    3002808486-2018-00536
    Event Type
    Injury
    Date Received
    May 8, 2018
    Date of Event
    May 17, 2017
    Report Date
    August 16, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002347004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

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

    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: (B)(6). REGISTRATION NO.: (B)(4). H6) EC METHOD CODE: 4109 - HISTORICAL DATA ANALYSIS. 4117 - DEVICE NOT ACCESSIBLE FOR TESTING. EC RESULT CODE: 4247 - APPROPRIATE TERM/CODE NOT AVAILABLE (DEVICE USED FOR INDICATION OUTSIDE OF INTENDED USE). EC CONCLUSION CODE: 4315 - CAUSE NOT ESTABLISHED . SUMMARY OF INVESTIGATIONAL FINDINGS: THE COMPLAINT STATES THAT THE PATIENT UNDERWENT TEVAR DUE TO ACUTE THORACIC AORTIC DISSECTION TYPE B. THE FALSE LUMEN STARTED PROXIMALLY IN ZONE 3 AND EXTENDED TO BELOW THE AORTIC BIFURCATION ON THE RIGHT SIDE. NO RE-ENTRY TEARS WERE OBSERVED AND FALSE LUMEN WAS PATENT. ACCORDING TO THE REPORTED INFORMATION, THE PATIENT ALSO HAD A THORACIC AORTIC ANEURYSM. THE PROXIMAL NECK DIAMETER WAS 34MM, THE PROXIMAL NECK LENGTH WAS 15MM AND THE DISTAL NECK DIAMETER WAS 28MM. THE COMPLAINT DEVICE WAS IMPLANTED PROXIMALLY FROM ZONE 1, WITH STENT GRAFT FABRIC COMPLETELY COVERING THE LSA. NO EVENTS WERE OBSERVED DURING THE PROCEDURE. FORTY SEVEN DAYS LATER, A SECONDARY PROCEDURE WAS PERFORMED TO CORRECT A TYPE 1 ENDOLEAK WITH A DISTAL EXTENSION STENT GRAFT (NO INFORMATION ON MANUFACTURER) ALONG WITH LSA REVASCULARIZATION. NO EVENTS WERE REPORTED DURING OR AFTER THE SECONDARY INTERVENTION. NO IMAGES WERE PROVIDED AND THE PRODUCT WAS NOT RETURNED. THE ZTA DEVICE WAS USED OUTSIDE OF INTENDED USE FOR TREATMENT OF DISSECTION. THE IFU STATES THAT THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ANEURYSMS/ULCERS OF THE DESCENDING THORACIC AORTA HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR INCLUDING NONANEURYSMAL AORTIC SEGMENTS (FIXATION SITES) PROXIMAL AND DISTAL TO THE ANEURYSM WITH A LENGTH OF AT LEAST 20 MM. FURTHERMORE, ENDOLEAK IS LISTED AS A POTENTIAL ADVERSE EVENT. HOWEVER, AS THE IFU ALSO STATES THAT THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT COMPONENTS HAVE NOT BEEN FORMALLY TESTED IN PATIENT POPULATIONS HAVING DISSECTIONS, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED TYPE 1 ENDOLEAK. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2017 (ONE DAY PRE-PROCEDURE), THE PRE-PROCEDURE IMAGING WAS PERFORMED. IT REVEALED NO CIRCUMFERENTIAL CALCIFICATIONS OF MAIN ACCESS VESSEL. NO VESSEL WALL THROMBOSIS IN AORTIC NECKS > 50% OF CIRCUMFERENCE WAS OBSERVED. THE PROXIMAL NECK WAS TAPERED, THE PROXIMAL NECK DIAMETER WAS 34 MM AND THE PROXIMAL NECK LENGTH WAS 1.5 MM. THE DISTAL NECK WAS ALSO TAPERED. THE DISTAL NECK DIAMETER WAS 28 MM. THE ANEURYSM/DISSECTION DIAMETER WAS 66 MM. PROXIMAL START OF FALSE LUMEN WAS ZONE 3 AND THE MOST DISTAL EXTEND OF FALSE LUMEN WAS BELOW THE AORTIC BIFURCATION ON THE RIGHT SIDE. NO RE-ENTRY TEARS WERE VISIBLE AND THE FALSE LUMEN WAS PATENT. ON (B)(6) 2017 THE PATIENT UNDERWENT SURGERY DUE TO HIS THORACIC AORTIC DISSECTION. THE DELIVERY AND DEPLOYMENT WAS CONSIDERED SUCCESSFUL LSA WAS INTENTIONALLY AND COMPLETELY COVERED BY THE STENT GRAFT FABRIC AND THE PROXIMAL ZONE OF STENT GRAFT IMPLANTATION WAS ZONE 1. NO ADDITIONAL PROCEDURES WERE PERFORMED AND NO EVENTS WAS OBSERVED DURING THE PROCEDURE. ON (B)(6) 2017 (47 POST-PROCEDURE), THE PATIENT UNDERWENT A SECONDARY INTERVENTION DUE TO A TYPE 1 ENDOLEAK. IT WAS AN ENDOVASCULAR PROCEDURE WHERE AN ADDITIONAL STENT GRAFT WAS PLACED (DISTAL EXTENSION) AND A SURGICAL PROCEDURE WHERE A LSA REVASCULARIZATION WAS DONE. PATIENT OUTCOME: THE PATIENT REMAINS IN THE STUDY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339669 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3389648 10827002347004

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R