BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 6310144 · Received February 8, 2017

    Report

    Report Number
    3002808486-2017-00358
    Event Type
    Death
    Date Received
    February 8, 2017
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002527130
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION IS BASED ONLY ON THE EVENT DESCRIPTION AS NO DEVICE OR IMAGES WERE PROVIDED. WITHOUT THE DEVICE AND/OR IMAGES WE ARE UNABLE TO GIVE AN EXACT ROOT CAUSE TO THIS EVENT AND NO CONCLUSION CAN BE DRAWN. HOWEVER, IT IS PLAUSIBLE, THAT THE INCIDENT COULD BE RELATED TO PATIENT CONDITION (CALCIFICATION) OR MISPLACEMENT OF THE STENT GRAFT WHICH CAN LEAD TO A TYPE 1 ENDOLEAK. THIS IS ALSO SUPPORTED BY THE PHYSICIANS COMMENT "I GUESS THE ENDOLEAK WAS DUE TO SLIGHT CALCIFICATION IN THE NECK" NOTHING INDICATES THAT THE ENDOLEAK IS RELATED TO A DEVICE FAILURE AND NO EVIDENCE EXISTS TO CONFIRM THE PRODUCT WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. IT SHOULD BE STATED THAT THE ESBE-DEVICE IS A DISTAL EXTENTION-DEVICE AND IS NOT SUITABLE TO USE AS A PROXIMAL EXTENTION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A (B)(6) FEMALE PATIENT UNDERWENT TAA REPAIR. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR, ALTHOUGH THE PROXIMAL NECK WAS SLIGHTLY CALCIFIED. THE TAA WAS IN THE OUTER CURVATURE OF THE ARCH AND THE BIGGEST PART WAS 53MM. ZTEG-2PT-38-202-PF WAS INSERTED FROM THE RIGHT. THE RIGHT COMMON FEMORAL ARTERY AND THE EXTERNAL ILIAC ARTERY WERE 8.5MM, AND THE COMMON ILIAC ARTERY WAS 10MM. THE STENT GRAFT WAS PLACED AS LEVELED AT THE TARGET SITE AND PROXIMAL TYPE I ENDOLEAK WAS CONFIRMED BEFORE BALLOONING.((B)(4)) THE PHYSICIAN PERFORMED BALLOONING WITH OTHER MANUFACTURER'S BALLOON CATHETER, BUT THE LEAK PERSISTED. TO SOLVE THE ENDOLEAK, HE INSERTED TBE-38-77-PF, BUT IT GOT CAUGHT IN THE PREVIOUSLY PLACED STENT GRAFT.((B)(4)) HE GAVE UP USING IT AND TRIED ESBE-38-77-T-JP, BUT IT WOULD NOT ADVANCED TO THE TARGET SITE EITHER.((B)(4)) HE TRIED PULL THROUGH TECHNIQUE, BUT IT DIDN'T SOLVE THE PROBLEM. THEN HE FOUND DAMAGE IN THE RIGHT VESSEL. HE DETERMINED IT WAS DUE TO INSERT/ADVANCE/REMOVE OF THOSE TWO DEVICES AND PLACED GORE'S EXCLUDER LEG TO TREAT THE VESSEL DAMAGE. THE ENDOLEAK WAS NOT GONE BUT THE PROCEDURE WAS COMPLETED. THE PATIENT WILL BE FOLLOWED CLOSELY. ADDITIONAL INFORMATION RECEIVED 28AUG2014: PRIOR TO TEVAR, DEBRANCH FROM THE RCCA TO THE LCCA TO THE LSCA WAS PERFORMED. PATIENT OUTCOME: ADDITIONAL INFORMATION RECEIVED 28AUG2014: AFTER THE INITIAL PROCEDURE, THE PATIENT WAS ONCE DECANNULATED BUT ASSOCIATED WITH BILATERAL VOCAL FOLD PARALYSIS. THEN SHE WAS ASSOCIATED WITH RESPIRATORY FAILURE FROM UPPER AIRWAY NARROWING, SO SHE WAS INTUBATED AGAIN AND UNDER RESPIRATORY CONTROL FOR LONG PERIOD. THEN SHE WAS ASSOCIATED WITH VASCULAR GRAFT INFECTION FROM CERVICAL WOUND INFECTION, SO AUTOGENOUS VEIN BYPASS FOR BOTH AXILLARY ARTERIES AND THE VEIN TO THE LSCA WAS PERFORMED. HOWEVER THE WOUND INFECTION AND THE SEPTICEMIA WERE PROLONGED. SHE SLOWLY RECOVERED AND STARTED GAIT TRAINING. HOWEVER SHE SUDDENLY DEVELOPED VENTRICULAR FIBRILLATION 150 DAYS AFTER THE INITIAL PROCEDURE AND WENT INTO CARDIAC ARREST. HER HEARTBEAT WAS BACK ONCE, BUT SHE WAS ASSOCIATED WITH CEREBRAL INFARCTION AND DECEASED 161 DAYS AFTER THE INITIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94965 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002527130

    Patients

    Seq Age Sex Outcome Treatment
    1 73 Death| R