BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT

    MDR report key: 14563966 · Received June 1, 2022

    Report

    Report Number
    3002808486-2022-00753
    Event Type
    Injury
    Date Received
    June 1, 2022
    Date of Event
    May 20, 2022
    Report Date
    October 8, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002474670
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). PMA: P180001. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). INVESTIGATION IS STILL IN PROGRESS. 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 · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A 72-YEAR-OLD FEMALE PATIENT WITH A THORACOABDOMINAL ANEURYSM WAS TREATED WITH A ZDEG-PT-32-202-PF-US (COMPLAINT DEVICE), WHICH WAS MODIFIED PRIOR TO IMPLANTATION AND THE STENT GRAFT WAS RESHEATED. 4 FENESTRATIONS FOR THE CELIAC ARTERY, SMA (SUPERIOR MESENTERIC ARTERY), LEFT AND RIGHT RENAL ARTERY HAVE BEEN DONE. THE PHYSICIANS DEPLOYED THE STENT GRAFT, WERE ABLE TO GET OUT THE FENESTRATIONS TO PLACE STENTS OUT THE FENESTRATIONS. A SMALL DISSECTION IN THE CELIAC ARTERY HAS OCCURRED BUT THE PHYSICIANS WERE ABLE TO STENT AND FIX IT. THEN ANOTHER DISSECTION IN THE SMA OCCURRED. THIS TIME THE PHYSICIANS WERE NOT ABLE TO FIX IT RIGHT AWAY. A BYPASS HAS BEEN PERFORMED. A LONGER HOSPITAL STAY HAS BEEN EXPECTED. NO IMAGING WAS PROVIDED FOR INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. ACCORDING TO THE IFU, ZDEG IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH TYPE B AORTIC DISSECTION. CONSEQUENTLY, USE OF ZDEG DEVICE FOR TREATMENT OF A THORACOABDOMINAL ANEURYSM IS OUTSIDE OF INTENDED USE. ADDITIONALLY, DEVICE MODIFICATION IS NOT SUPPORTED BY THE INSTRUCTIONS FOR USE OR CLINICAL TESTING OF THE DEVICE. BASED ON THE PROVIDED INFORMATION IT HAS NOT BEEN POSSIBLE TO ESTABLISH A CONCLUSIVE CAUSE OF THE REPORTED EVENT AS THE STENT GRAFT WAS MODIFIED BEFORE USE. 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 INITIAL REPORTER: PHYSICIAN MODIFIED GRAFT AND CREATED 4 FENESTRATIONS FOR THE SYLIAC SMA LEFT AND RIGHT RENAL. THEY DEPLOYED THE GRAFT AND WERE ABLE TO GET OUT THE FENESTRATIONS AND WERE ABLE TO PLACE STENTS OUT THE FENESTRATIONS. BUT THEY HAD A SMALL DISSECTION IN THE SILLIAC WHICH THEY WERE ABLE TO STENT AND FIX. THEN ANOTHER DISSECTION IN THE SMA (SUPERIOR MESENTERIC ARTERY) WHICH THEY WERE NOT ABLE TO FIX RIGHT AWAY AND HAD TO GO IN AND DO A BYPASS ON. PATIENT OUTCOME: THE EVENT DID REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE: BYPASS THE PATIENT DID NOT REPORT ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT WAS HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE THIS OCCURRENCE: THERE PROBABLY WILL BE A LONGER THAN EXPECTED HOSPITAL STAY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 01JUN2022: FENESTRATIONS WERE CREATED BEFORE THE CASE. THEY WERE CREATED ON THE TABLE AND THEN RESHEATHED. NO ISSUES WITH IT. THEY WERE NOT DONE IN THE PT.

    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
    1731410 ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G47467 E4239187 10827002474670

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention