BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS

    MDR report key: 10739735 · Received October 27, 2020

    Report

    Report Number
    3002808486-2020-00993
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    August 22, 2019
    Report Date
    November 18, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002449227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). EC METHOD CODE: ANALYSIS OF DATA PROVIDED BY USER/THIRD PARTY ((B)(4)) SUMMARY OF INVESTIGATIONAL FINDINGS: AN 84 YEAR OLD MALE PATIENT UNDERWENT TEVAR ON THE SUSPICION OF PENDING ANEURYSM RUPTURE, TYPE 1B ENDOLEAK AND RIGHT CORONARY ARTERY OCCLUSION. TWO YEARS PREVIOUSLY THE PATIENT HAD TWO COMPETITOR STENT GRAFTS IMPLANTED, PLACED FROM THE ASCENDING- TO THE DESCENDING AORTA. DURING THE TEVAR TWO COMPETITOR STENTGRAFT WITH THE MEASUREMENTS 34MM X 150MM AND 30MM X 100 MM WERE PLACED FROM 10-20MM FROM THE LCCA (LEFT CIRCUMFLEX CORONARY ARTERY), INSIDE THE PREVIOUSLY IMPLANTED STENT GRAFTS, EXTENDING TO THE DESCENDING AORTA. THEN THE PHYSICIAN ATTEMPTED TO IMPLANT THE ZTA-DE-38-91-W1 (COMPLAINT DEVICE) AT THE PROXIMAL END OF THE 34MMX150MM STENTGRAFT, HOWEVER THE USER FELT RESISTANCE, AND WAS NOT ABLE TO DELIVER THE SYSTEM TO THE TARGET PLACE. THEREFORE, THE USER ATTEMPTED TO DEPLOY AT THE REACHED AREA (INSIDE THE 34MMX150MM STENTGRAFT) BUT FAILED. THE PHYSICIAN CHANGED THE WIRE GUIDE, WITH NO EFFECT. THE COMPLAINT DEVICE WAS REMOVED AND REPLACED WITH ZTA-DE-34-112-W1 AND AN ADDITIONAL ZTA-DE-30-108-W1 WAS IMPLANTED. DISAPPEARANCE OF THE DISTAL ENDOLEAK WAS CONFIRMED AND THE TEVAR WAS COMPLETED. THE PHYSICIAN ATTEMPTED TO DEPLOY THE COMPLAINT DEVICE OUTSIDE THE PATIENT¿S BODY, BUT RESISTANCE WAS STILL THERE, AND THE DEVICE COULD NOT BE DEPLOYED. THE PHYSICIAN COMMENTS THAT ANGIOGRAPHY REVEALED DEFORMATION OF ONE OF THE PREVIOUSLY IMPLANTED STENTGRAFT AND THAT THE COMPLAINT DEVICE WAS CAUGHT IN THIS DEFORMATIONS, WHICH MIGHT HAVE DAMAGED THE DEVICE. NO ADVERSE EFFECTS TO THE PATIENT WAS REPORTED. IT WAS NOTED THAT THE PATIENT ANATOMY HAD NO NOTABLE TORTUOSITY OR NARROWING NEITHER IN THE ACCESS VESSELS NOR IN THE AORTA. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUTSIDE OF SPECIFICATIONS. THE WHOLE DEVICE, EXCEPT FOR THE TRANSPORT STYLET, WAS RETURNED FOR PRODUCT EVALUATION. THE SHEATH WAS RETRACTED AND THE STENTGRAFT RELEASED WITHOUT DIFFICULTIES. THE CAUSE FOR THE REPORTED FAILURE CANNOT BE DETERMINED, BASED ON THE PRODUCT EVALUATION. PER THE IFU "STOP AND DO NOT CONTINUE ADVANCING THE WIRE GUIDE OR ANY PORTION OF THE INTRODUCTION SYSTEM PRIOR TO REMOVING CAUSES OF RESISTANCE IF RESISTANCE IS FELT DURING ADVANCING THE WIRE GUIDE OR ANY PORTION OF THE INTRODUCTION SYSTEM¿" AND "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." BASED ON THE INFORMATION PROVIDED A LIKELY CAUSE FOR THIS EVENT CANNOT BE ESTABLISHED. COOK WILL REOPEN THE CASE IF FURTHER INFORMATION OR IMAGING ARE PROVIDED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR 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.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF#: (B)(4). SIMILAR TO DEVICE UNDER PMA/510(K): P140016. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: TWO YEARS BEFORE THE TEVAR, TWO KAWASUMI'S NAJUTA STENT GRAFTS WERE PLACED FROM THE ASCENDING AORTA TO THE DESCENDING AORTA. ON (B)(6) 2019 SUSPICION OF THE ANEURYSM RUPTURE, TYPE IB ENDOLEAK AND RIGHT CORONARY ARTERY OCCLUSION WERE CONFIRMED SO URGENT TEVAR WAS PERFORMED. BEFORE THE TEVAR, NO NOTABLE NARROWING AND TORTUOUSITY WERE CONFIRMED IN THE ACCESS ROUTE. FIRST, MEDTRONIC'S VALIANT STENT GRAFTS (34MM X 150MM AND 30MM X 100 MM) WERE PLACED. PROXIMAL TIP OF THE VALIANT (34MM X 150MM ) WAS AT 10MM TO 20MM DISTALLY AWAY FROM THE LEFT COMMON CAROTID ARTERY. DISTAL TIP OF THE VALIANT (30MM X 100 MM) WAS AT THE DESCENDING AORTA. THEN, THE USER ATTEMPTED TO PLACE ZTA-DE-38-91-W1 (LOT E3794169) AT THE PROXIMAL TIP OF THE VALIANT (34MM X 150MM ) BUT THE USER FELT STRONG RESISTANCE DURING ITS DELIVERY AND HE WAS NOT ABLE TO ADVANCE THE DELIVERY SYSTEM TO THE TARGET PLACE. THEREFORE, THE USER ATTEMPTED TO DEPLOY THE STENT AT WHERE THE DELIVERY SYSTEM REACHED BUT THE STENT GRAFT WAS NOT DEPLOYED. THE USER CHANGED WIRE GUIDES BUT THE STENT GRAFT WAS STILL NOT DEPLOYED. ZTA-DE-38-91-W1 (LOT E3794169) WAS REMOVED FROM THE BODY AND THE USER ATTEMPTED TO DEPLOY THE STENT GRAFT OUTSIDE THE BODY BUT HE FELT STRONG RESISTANCE AND FAILED TO DEPLOY IT. ZTA-DE-34-112-W1 (LOT E3868339) WAS USED INSTEAD AND WAS PLACED AT WHERE ZTA-DE-38-91-W1 (LOT E3794169) REACHED. TYPE IB ENDOLEAK WAS STILL EXIST SO ZTA-DE-30-108-W1 (LOT E3876671) WAS PLACED AT THE DISTAL SIDE OF THE VALIANT STENT GRAFT (30MM X 100 MM). DISAPPEARANCE OF THE TYPE IB ENDOLEAK WAS CONFIRMED AND THE TEVAR WAS COMPLETED. PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206408 ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3794169 10827002449227

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR