BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 5905938 · Received August 26, 2016

    Report

    Report Number
    3002808486-2016-00988
    Event Type
    Injury
    Date Received
    August 26, 2016
    Date of Event
    May 20, 2016
    Report Date
    August 17, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002346915
    PMA / PMN Number
    P140016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION OF THIS COMPLAINT WAS ONLY BASED ON THE INFORMATION PROVIDED IN THE EVENT DESCRIPTION ALONG WITH HISTORY RECORD OF THE DEVICE. THE DESCRIPTION OF EVENT STATES THAT THE PATIENT RECEIVED ONE PROXIMAL COMPONENT AND WAS THEREAFTER DISCHARGED. ACCORDING TO THE IFU SENT WITH THE PRODUCT, THE USE OF THIS PRODUCT REQUIRES THE USE OF A DISTAL COMPONENT ALSO AS THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT IS A TWO-PIECE CYLINDRICAL ENDOVASCULAR GRAFT CONSISTING OF PROXIMAL AND DISTAL COMPONENTS. THE USE OF TWO COMPONENTS PROVIDES ACTIVE FIXATION AT BOTH THE PROXIMAL AND DISTAL SEAL SITES. THIS EXPLAINS THE APPEARANCE OF TYPE IB ENDOLEAK. THE SECOND REPORTED EVENT RELATES TO THE OCCURRENCE OF AORTOBRONCHIAL FISTULA. AORTOBRONCHIAL FISTULA IS A POTENTIALLY LETHAL COMPLICATION SECONDARY TO THE REPAIR OF A DESCENDING THORACIC ANEURYSM ADDRESSED IN THE IFU AS AN ADVERSE EVENT. LASTLY, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED DEATH EVENT IS RELATED TO THE DEVICE OR PATHOLOGICAL CHANGES. NOTHING INDICATES THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPEC OR DID NOT PERFORM AS INTENDED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016032. (B)(4). NAME AND ADDRESS FOR IMPORTER SITE: (B)(4). SIMILAR TO DEVICE UNDER 510(K): P140016. SUMMARY OF INVESTIGATIONAL FINDINGS: REINVESTIGATION DUE TO ADDITIONAL EVALUATION OF COMPLAINT. THE INVESTIGATION OF THIS COMPLAINT WAS BASED ON REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORDS AND THE INSTRUCTIONS FOR USE (IFU). BASED ON THE LIMITED INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE IFU RECOMMENDS THE USE OF BOTH A PROXIMAL AND A DISTAL COMPONENT. HOWEVER, THERE ARE CASES WHERE THE USE OF A SINGLE COMPONENT IS SUFFICIENT FOR AN ADEQUATE DISTAL SEAL ZONE. THE IFU STATES THAT A PROXIMAL COMPONENT MAY BE USED INDEPENDENTLY FOR ULCERS/SACCULAR ANEURYSMS. AS IMAGING FOR THIS PATIENT IS NOT AVAILABLE, IT CANNOT BE DETERMINED IF TREATMENT WITH BOTH A PROXIMAL AND DISTAL COMPONENT COULD HAVE BEEN BENEFICIAL FOR THIS PATIENT. IT HAS NOT BEEN POSSIBLE TO DETERMINE IF THE REPORTED DEATH EVENT IS RELATED TO THE DEVICE OR PATHOLOGICAL CHANGES. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. PER QUALITY ENGINEERING ASSESMENT, THE ASSOCIATED RISKS IDENTIFIED IN THIS ANALYSIS HAS BEEN DEEMED ACCEPTABLE. USE OF THIS DEVICE WILL NOT CREATE A REASONABLE PROBABILITY THAT ADVERSE HEALTH CONSEQUENCES WILL OCCUR. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2016, THE PATIENT RECEIVED ONE PROXIMAL COMPONENT: ZTA-P-32-155, LOT # E3381987. NO ADDITIONAL PROCEDURES OR DEVICES WERE NEEDED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2016. ON (B)(6) 2016 (26 DAYS PP), THE ONE-MONTH FOLLOW-UP CT WAS COMPLETED. THERE WERE NO ENDOLEAKS OR OTHER PROBLEMS NOTED. ON (B)(6) 2016 (63 DAYS PP), THE PATIENT WAS NOTED TO HAVE AN AORTOBRONCHIAL FISTULA WHICH WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. ON (B)(6) 2016 (65 DAYS PP), THE PATIENT UNDERWENT A SECONDARY INTERVENTION TO TREAT A DISTAL TYPE I ENDOLEAK AND THE AORTOBRONCHIAL FISTULA. A DISTAL EXTENSION WAS PLACED. FOLLOWING THE SI, A DISTAL TYPE I ENDOLEAK REMAINED. ON (B)(6) 2016 (72 DAYS PP), THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2016 (135 DAYS PP), THE PATIENT DIED AT HOME. THE CAUSE OF DEATH IS UNKNOWN AND AN AUTOPSY WAS NOT PERFORMED. PATIENT OUTCOME: THE PATIENT DIED AT HOME ON (B)(6) 2016 (135 DAYS PP).

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2016, THE PATIENT RECEIVED ONE PROXIMAL COMPONENT: ZTA-P-32-155, LOT # E3381987. NO ADDITIONAL PROCEDURES OR DEVICES WERE NEEDED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2016. ON (B)(6) 2016 (26 DAYS PP), THE ONE-MONTH FOLLOW-UP CT WAS COMPLETED. THERE WERE NO ENDOLEAKS OR OTHER PROBLEMS NOTED. ON (B)(6) 2016 (63 DAYS PP), THE PATIENT WAS NOTED TO HAVE AN AORTOBRONCHIAL FISTULA WHICH WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. ON (B)(6) 2016 (65 DAYS PP), THE PATIENT UNDERWENT A SECONDARY INTERVENTION TO TREAT A DISTAL TYPE I ENDOLEAK AND THE AORTOBRONCHIAL FISTULA. A DISTAL EXTENSION WAS PLACED. FOLLOWING THE SI, A DISTAL TYPE I ENDOLEAK REMAINED. ON (B)(6) 2016 (72 DAYS PP), THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2016 (135 DAYS PP), THE PATIENT DIED AT HOME. THE CAUSE OF DEATH IS UNKNOWN AND AN AUTOPSY WAS NOT PERFORMED. PATIENT OUTCOME: THE PATIENT DIED AT HOME ON (B)(6) 2016 (135 DAYS PP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561038 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE 10827002346915

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| R