BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 12529269 · Received September 24, 2021

    Report

    Report Number
    1820334-2021-02220
    Event Type
    Malfunction
    Date Received
    September 24, 2021
    Date of Event
    August 30, 2021
    Report Date
    October 1, 2021
    Manufacturer
    COOK INC
    Product Code
    MIH
    UDI-DI
    10827002552415
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: UPON FURTHER INVESTIGATION, THIS EVENT NO LONGER MEETS THE REPORTING CRITERIA. DURING REVIEW OF RETURNED IMAGING, THE EXPERT IMAGE REVIEWER NOTED THAT THE CT SCAN IDENTIFIED THE REPORTED ENDOLEAK TO BE BETWEEN PROXIMAL AND DISTAL ZFEN COMPONENTS, NOT THE ZSLE-20-56-ZT. THE ZFEN COMPONENTS ARE NOT MANUFACTURED BY COOK INC. THEREFORE, THIS DEVICE WAS NOT INVOLVED IN THE REPORTED ENDOLEAK, AND NO OTHER PROBLEMS WITH THIS DEVICE WERE DETECTED. AS SUCH, NO FURTHER REPORTS REGARDING THIS EVENT WILL BE SUBMITTED. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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 · 1

    THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TYPE 3 ENDOLEAK OCCURRED ON A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG FOLLOWING A FENESTRATED ENDOVASCULAR ANEURYSM REPAIR (FEVAR) PROCEDURE. DURING THE PROCEDURE ON (B)(6) 2019, THE PATIENT RECEIVED 5 COOK DEVICES AND 2 COMPETITOR DEVICES, INCLUDING A MAIN BODY DEVICE, A DISTAL BODY DEVICE, A RIGHT ILIAC LEG GRAFT, A LEFT ILIAC ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT (ZSLE-20-56-ZT), TWO COVERED STENTS, AND A VASCULAR SELF-EXPANDING STENT. IT WAS NOTED THE BILATERAL COMMON ILIACS WERE TORTUOUS (LEFT GREATER THAN THE RIGHT). AN ANGIOGRAM REVEALED THE SUPERIOR MESENTERIC ARTERY TO BE PATENT. AN AORTOGRAM SHOWED PATENCY OF THE BILATERAL RENAL ARTERY STENTS. A LEFT LOWER EXTREMITY ANGIOGRAM REVEALED PATENCY OF THE LEFT ILIAC LIMB AND LEFT ILIAC ARTERY. THE PATIENT WAS EXTUBATED IN HEMODYNAMICALLY STABLE CONDITION AND TAKEN TO THE POST ANESTHESIA CARE UNIT IN HEMODYNAMICALLY STABLE CONDITION. ON (B)(6) 2019 (2 MONTHS POST IMPLANT PROCEDURE), A CT SCAN DEMONSTRATED STABLE REPAIR WITH SLIGHT DECREASE OF THE EXCLUDED ANEURYSM SAC. SOME STENOSIS WAS NOTED IN THE SUPERIOR MESENTERIC ARTERY. ON (B)(6) 2019 (5 MONTHS POST IMPLANT PROCEDURE), A CT SCAN SHOWED A REDUCTION IN HER ABDOMINAL AORTIC ANEURYSM SIZE TO 5.9 X 6CM, DOWN FROM 6.2 X 6.4CM. THERE WAS NO EVIDENCE OF A TYPE I OR TYPE II ENDOLEAK. "QUESTIONABLE" LEFT EXTERNAL ILIAC ARTERY STENOSIS WAS NOTED AT THE END OF THE ENDOGRAFT AT AN AREA OF A SHARP BEND. IT WAS REPORTED AS BEING 50%-75% STENOSIS, AND HAVING A DISSECTION THOUGH NO ACTUAL DISSECTION WAS SEEN. A SOFT LEFT ILIAC "BRUIT" WAS HEARD. ON (B)(6) 2021, THE PATIENT WAS DISCOVERED UNCONSCIOUS AT HOME BY A FAMILY MEMBER AND BROUGHT TO THE HOSPITAL. IMAGING REVEALED AN ENLARGED ANEURYSM SAC AND DEVICE COMPONENT SEPARATION. A TYPE III ENDOLEAK WAS IDENTIFIED BETWEEN THE MAIN BODY AND LEFT ILIAC LEG DEVICE. THE PATIENT HAS REFUSED TREATMENT. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. THE MAIN BODY DEVICE IS REPORTED UNDER MANUFACTURER REPORT # 9680654-2021-00016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426557 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC G55241 9335062 10827002552415

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Hospitalization 10MM BALLOON| 21G NEEDLE| 5FR MICROPUNCTURE ACCESS SET| 6FR SHEATH| 8X2MM BALLOON| 9X2MM BALLOON| AMPLATZ WIRE| ANGLED GLIDE WIRE| BENTSON WIRE| CODA BALLOON| COOK ZFEN-D-12-45-76-C| COOK ZFEN-P-2-28-124-R| COOK ZIV6-35-80-6-20| COOK ZSLE-16-74-ZT| ICAST STENT (QT.2)| IVUS CATHETER| KUMPE CATHETER| PROGLIDE CLOSURE DEVICES (QT.2)| ROSEN WIRE| VANSHIE 3 CATHETER| VANSHIE 4 CATHETER