BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 8820661 · Received July 24, 2019

    Report

    Report Number
    3002808486-2019-01037
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    June 24, 2019
    Report Date
    July 16, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002346878
    PMA / PMN Number
    P140016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A MALE PATIENT UNDERWENT TEVAR AND HAD A ZTA-P-30-155 IMPLANTED. IT WAS REPORTED THAT WHEN THE STENT GRAFT WAS DEPLOYED THE LAST STENT WAS EXPOSED BUT 2 MM WAS STILL INSIDE THE INNER SYSTEM. IT WAS REPORTED THAT THE OUTER SHEATH WAS FULLY PULLED BACK TOWARDS THE ROTATION HANDLE. THE STENT WAS RELEASED AFTER SOME STRUGGLE FROM THE PHYSICIAN. THE PATIENT EXPERIENCED A BLOOD PRESSURE BOOST OF 24 SYSTOLIC, HOWEVER THE PROCEDURE WAS COMPLETED WITH THE STENTGRAFT PLACED AS INTENDED, AND NO OTHER ADVERSE EFFECTS TO THE PATIENT WAS REPORTED. SIX IMAGES OF THE IMPLANTATION PROCEDURE ANGIOGRAPHY PHOTOGRAPHED OFF AN ANGIOGRAPHY MONITOR WAS PROVIDED AND REVIEWED BY AN IMAGING EXPERT. PER THE FINDINGS OF THE IMAGING REVIEW: ¿THREE IMAGES DEMONSTRATE STRETCHING OF THE FLEXOR INTRODUCER SHEATH AFTER DEPLOYMENT AND DELIVERY SYSTEM TIP RETRACTION BACK INTO THE FLEXOR INTRODUCER SHEATH. THE DELIVERY SHEATH COILS WERE STRETCHED OVER A LENGTH OF 62 MM BEGINNING 38 MM FROM THE FLEXOR INTRODUCER SHEATH TIP. THE MOST SEVERELY STRETCHED SEGMENT WAS BUNCHED TOGETHER BY THE RETRACTED DILATOR TIP. PER THE IMAGING REVIEWER¿S IMPRESSION BECAUSE THE FLEXOR INTRODUCER SHEATH STRETCHING BEGAN APPROXIMATELY 38 MM FROM THE TIP, THE SHEATH BOUND MORE PROXIMALLY THAN THE ENDOGRAFT, LIKELY WITH THE GREY POSITIONER. THE OPERATOR STRETCHED THE FLEXOR INTRODUCER SHEATH UNTIL THE BINDING WAS OVERCOME. THE CAUSE OF THE BINDING CANNOT BE DETERMINED ON THE PROVIDED IMAGING. IT IS NOTED THAT THE REPORTED TRANSIENT BLOOD PRESSURE ELEVATION WAS CONSISTENT WITH THE INABILITY TO COMPLETE RETRACT THE FLEXOR INTRODUCER SHEATH PAST THE DISTAL ENDOGRAFT. THE REPORT STATES THAT RETRACTION WAS HALTED AT THE LAST 2 MM. THIS WOULD HAVE OCCLUDED THE AORTA AND TRANSIENTLY INCREASED BLOOD PRESSURE AS DESCRIBED. A REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. THE IFU STATES: IF EXTREME DIFFICULTY IS ENCOUNTERED WHEN ATTEMPTING TO WITHDRAW THE SHEATH, PLACE THE DEVICE IN A LESS TORTUOUS POSITION THAT ENABLES THE SHEATH TO BE RETRACTED. VERY CAREFULLY WITHDRAW THE SHEATH UNTIL IT JUST BEGINS TO RETRACT, AND STOP. MOVE BACK TO ORIGINAL POSITION AND CONTINUE DEPLOYMENT. AN EXACT CAUSE FOR THIS EVENT CANNOT BE ESTABLISHED. BASED ON THE IMAGING REVIEW IT IS LIKELY THAT THE SHEATH WAS STRETCHED WHEN RETRACTED WHICH ELONGATED THE SHEATH TO AN EXTENT WHERE IT COVERED THE DISTAL 2 MM OF THE STENTGRAFT EVEN WHEN IT WAS FULLY RETRACTED. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS 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.

    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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED (B)(6) 2019: THE STENT WAS EXPOSED BUT 2MM STAND INSIDE THE INNER SYSTEM THE OUTER SHEATH WAS FULLY PULLED BACK TOWARDS THE ROTATION HANDLE. THE STENT GRAFT WAS NOT RELEASED THROUGH IFU¿S TROUBLESHOOTING OR DEVICE MANIPULATION.

    Additional Manufacturer Narrative · 1

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    WHEN DEPLOYING THE THORACIC PROSTHESIS THE LAST STENT GOT STUCK IN THE INTRODUCER. THE PATIENT DID A BLOOD PRESSURE BOOST AT 24 SYSTOLIC. THE PHYSICIAN STRUGGLED TO RELEASE THE LAST STENT. THE STENT END UP RELEASING ITSELF THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615395 ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3860877 10827002346878

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening