BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS

    MDR report key: 12850772 · Received November 22, 2021

    Report

    Report Number
    3002808486-2021-01968
    Event Type
    Injury
    Date Received
    November 22, 2021
    Date of Event
    October 28, 2021
    Report Date
    February 22, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002448831
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: ON (B)(6) 2021, A 94-YEAR-OLD MALE PATIENT UNDERWENT TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) BY LEFT APPROACH TO TREAT THE TAA (THORACIC AORTIC ANEURYSM). THE PATIENT WAS JUDGED TO BE SUITABLE FOR THE PROCEDURE. THERE WAS NO CALCIFICATION, STENOSIS OR ANY OTHER PROBLEM IN THE ACCESS ROUTE AND THE TARGET SITE. WIRE CANNULATION AND SECURING AN ANGIO ROUTE TO THE SMA WAS PERFORMED WITH A 7FR TWIN SHEATH FROM THE RIGHT GROIN. THE APPROACH WAS GAINED FROM THE LEFT GROIN. HEMOSTATIC DEVICES WERE USED IN BOTH GROINS UNDER LOCAL ANESTHESIA. THE DELIVERY SYSTEM OF ZTA-D-34-190-W1 WAS ADVANCED OVER LUNDERQUIST EXTENDED DOUBLE CURVED WIRE GUIDE. THE PHYSICIAN DEPLOYED THE STENT GRAFT AS FOLLOWING THE PROCEDURE, BUT HE COULD NOT CONFIRM EXPANSION OF THE DISTAL BARE STENT ON THE FLUOROSCOPY SCREEN. (HE CONFIRMED THAT THE WINDOW ON THE HANDLE TURNED GREEN WHEN HE SLID THE SLIDING HANDLE (BLACK GRIPPER). THEREFORE, THE TRIGGER WIRES WERE RELEASED WITH FOLLOWING THE RELEASE TROUBLE SHOOTING METHOD ON THE PACKAGE INSERT, THEN THE PHYSICIAN WAS CAREFUL NOT TO ADVANCE THE SHEATH TOO PROXIMAL AND ATTEMPTED TO DEPLOY THE DISTAL BARE STENT BY ADVANCING, WITHDRAWING, AND ROTATING THE GRAY POSITIONER. WITH THE MOVEMENT OF THE DELIVERY SYSTEM, THE STENT GRAFT WHICH HAD BEEN PLANNED TO BE PLACED JUST ABOVE THE SMA WAS PLACED AT SLIGHTLY MORE DISTAL THAN PLANNED IN THE DESCENDING AORTA AND BLOCKED HALF OF THE SMA. STENTING OVER THE SMA WAS ATTEMPTED, BUT IT WAS DIFFICULT TO PERFORM CANNULATION WITH A CATHETER. THE PHYSICIAN PERFORMED ANGIOGRAPHY AND JUDGED THAT THE SUFFICIENT BLOOD FLOW WAS SECURED, SO NO ADDITIONAL STENT WAS IMPLANTED. AFTER PLACEMENT OF ZTA-D, ZTA-P-38-217-W1 WAS PLACED IN THE PROXIMAL SIDE OF THE ZTA-D BELOW LSA IN THE AORTIC ARCH. SINCE OVERLAP LENGTH WAS NOT ENOUGH, ZTA-DE-38-91-W1 WAS ADDITIONALLY PLACED AT THE JUNCTION PART IN THE DESCENDING AORTA. NO ENDOLEAK WAS CONFIRMED AND THE PROCEDURE WAS FINISHED. ADDITIONAL INFORMATION WAS PROVIDED ON 29OCT2021 WHICH INDICATE THAT THE ADDITIONAL PLACEMENT OF THE ZTA-DE IS CONSIDERED NOT TO BE RELATED TO THE DIFFICULTY IN DEPLOYING THE DISTAL BARE STENT. THE ZTA-D DEVICE WAS RETURNED WITHOUT SHIPPING STYLET, STENT GRAFT, GRAY SAFETY LOCK KNOB, BLUE ROTATION HANDLE, GREEN MARKING RING AND TRIGGER WIRES AND A DEVICE EVALUATION WAS PERFORMED. DURING THE DEVICE EVALUATION THE FOLLOWING WAS OBSERVED: NO BARBS HAD PERFORATED THE SHEATH, MINOR SCRATCHES WERE OBSERVED ON THE SHEATH TIP AND SEVERAL SCRATCHES WERE OBSERVED ON THE INNER SIDE OF THE BOTTOM CAP GOING FROM ABOVE THE WIRE HOLE TOWARDS THE EDGE OF THE BOTTOM CAP, BUT DID NOT MAKE CONTACT WITH THE WIRE HOLE. THESE SCRATCHES ARE POSSIBLY CAUSED BY ONE OR SEVERAL BARBS AND MIGHT HAVE PROVIDED RESISTANCE WHEN WITHDRAWING THE BOTTOM CAP. THE EXACT CAUSE FOR THE REPORTED DIFFICULTY WITH EXPANSION OF THE DISTAL BARE STENT CANNOT BE DETERMINED BASED ON THIS PRODUCT EVALUATION. A SINGLE PRE-PROCEDURE CT WAS PROVIDED AND REVIEWED BY AN IMAGING EXPERT. PER THE FINDINGS OF THE IMAGING REVIEW: ¿TWO COMPONENTS ZENITH ALPHA THORACIC COMPONENTS WERE INTENDED TO EXCLUDE THORACIC AND SUPRARENAL AORTIC ANEURYSMAL DISEASE.¿ AND ¿THE IMPLANTATION SITE A WAS FUNNEL SHAPED DISTAL NECK WITH PLANNED EXCLUSION OF THE CA. THE DISTAL SEAL STENT WAS TO LAND JUST PROXIMAL THE SMA ORIGIN. THE NECK FUNNELED 33% FROM 33.7MM TO 25.2MM OVER 20MM.¿ AND ¿THE AORTIC LUMEN DIAMETER AT THE SMA TO THE LEFT RA ORIGIN IN WHICH THE BARE STENT WAS INTENDED TO LAND WAS 22.2MM AT THE SMA AND 20.0MM AT THE LEFT RA.¿ AND ¿ALTHOUGH THE DISTAL LANDING ZONE LACK ACUTE ANGULATION, THE ACCESS PATH FROM THE LEFT CFA TO THE SUPRARENAL ABDOMINAL AORTA WAS SEVERELY TORTUOUS.¿ PER THE FINDINGS THE IMAGING EXPERTS¿ IMPRESSIONS IS: ¿THE DISTAL FUNNEL SHAPED SEAL ZONE WAS OUTSIDE THE IFU. CONSEQUENTLY, THE 34MM ZTA-D BARE STENT WAS UNSHEATHED IN A 20-22MM DIAMETER LUMEN¿ ACCORDING TO THE INSTRUCTION FOR USE: ¿THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ANEURYSMS OR ULCERS OF THE DESCENDING THORACIC AORTA HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR." AND ¿KEY ANATOMIC ELEMENTS THAT MAY AFFECT SUCCESSFUL EXCLUSION OF THE THORACIC ANEURYSM OR ULCER INCLUDE, INVERTED FUNNEL SHAPE AT THE PROXIMAL FIXATION SITE OR A FUNNEL SHAPE AT THE DISTAL FIXATION SITE (GREATER THAN A 10% CHANGE IN DIAMETER OVER 20 MM OF FIXATION SITE LENGTH).¿ IN ADDITION, THE INSTRUCTION FOR USE STATES: ¿THE SAFETY AND EFFECTIVENESS OF THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT AND ANCILLARY COMPONENTS HAVE NOT BEEN EVALUATED IN THE FOLLOWING PATIENT POPULATIONS: INABILITY TO PRESERVE THE LEFT COMMON CAROTID ARTERY AND CELIAC ARTERY¿ AND ¿A DISTAL AORTIC NECK LENGTH OF AT LEAST 20 MM PROXIMAL TO THE CELIAC AXIS IS REQUIRED. THESE SIZING MEASUREMENTS ARE CRITICAL TO THE PERFORMANCE OF THE ENDOVASCULAR REPAIR.¿ REVIEW OF DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUTSIDE OF SPECIFICATIONS. AS ONLY PRE-PROCEDURE IMAGES WERE PROVIDED THE EVENT COULD NOT BE CONFIRMED BY THE IMAGING EXPERT. BASED ON THE INVESTIGATION IT HAS NOT BEEN POSSIBLE TO ESTABLISH A CAUSE FOR THE EVENT. INTERNAL ACTION HAS PREVIOUSLY BEEN INITIATED TO INVESTIGATE AND PREVENT THIS FAILURE FROM OCCURRING AND IS STILL IN PROGRESS. COOK WILL REOPEN THE INVESTIGATION IF FURTHER INFORMATION OR IMAGES IS RECEIVED. 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

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

    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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2021, (B)(6) MALE PATIENT UNDERWENT TEVAR BY LEFT APPROACH TO TREAT THE THORACIC AORTIC ANEURYSM (TAA). HE WAS JUDGED TO BE SUITABLE FOR THE PROCEDURE. THERE WAS NO CALCIFICATION, STENOSIS OR ANY OTHER PROBLEM IN THE ACCESS ROUTE AND THE TARGET SITE. NOTES OF THE PROCEDURE: WIRE CANNULATION AND SECURING AN ANGIO ROUTE TO THE SMA WAS PERFORMED WITH A 7FR TWIN SHEATH FROM THE RIGHT GROIN. THE APPROACH WAS GAINED FROM THE LEFT GROIN. HEMOSTATIC DEVICES WERE USED IN BOTH GROINS UNDER LOCAL ANESTHESIA. THE DELIVERY SYSTEM OF ZTA-D-34-190-W1/ E4051074 WAS ADVANCED OVER COOK¿S LUNDERQUIST EXTENDED DOUBLE CURVED WIRE GUIDE. THE PHYSICIAN STARTED DEPLOYED THE STENT GRAFT AS FOLLOWING THE PROCEDURE, BUT HE COULD NOT CONFIRM EXPANSION OF THE DISTAL BARE STENT ON THE FLUOROSCOPY SCREEN. (HE CONFIRMED THAT THE WINDOW ON THE HANDLE TURNED GREEN WHEN HE SLID THE SLIDING HANDLE (BLACK GRIPPER).) THEREFORE, THE TRIGGER WIRES WERE RELEASED WITH FOLLOWING THE RELEASE TROUBLE SHOOTING METHOD ON THE PACKAGE INSERT, THEN THE PHYSICIAN WAS CAREFUL NOT TO ADVANCE THE SHEATH TOO PROXIMAL AND ATTEMPTED TO DEPLOY THE DISTAL BARE STENT BY ADVANCING, WITHDRAWING AND ROTATING THE GRAY POSITIONER. WITH THE MOVEMENT OF THE DELIVERY SYSTEM, THE STENT GRAFT WHICH HAD BEEN PLANED TO BE PLACED JUST ABOVE THE SMA WAS ACTUALLY PLACED AT SLIGHTLY MORE DISTAL THAN PLANNED IN THE DESCENDING AORTA AND BLOCKED HALF OF THE SMA. STENTING OVER THE SMA WAS ATTEMPTED, BUT IT WAS DIFFICULT TO PERFORM CANNULATION WITH A CATHETER. THE PHYSICIAN PERFORMED ANGIOGRAPHY AND JUDGED THAT THE SUFFICIENT BLOOD FLOW WAS SECURED, SO THE PROCEDURE OF PLACING THE STENT GRAFT OF ZTA-D-34-190-W1/ E4051074 WAS FINISHED AS IT WAS. AFTER PLACEMENT OF ZTA-D-34-190-W1/ E4051074, ZTA-P-38-217-W1/ E4078256 WAS PLACED IN THE PROXIMAL SIDE OF THE ZTA-D-34-190-W1 BELOW THE LEFT SA IN THE AORTIC ARCH. SINCE OVERLAP LENGTH WAS NOT ENOUGH, ZTA-DE-38-91-W1/ E4053608 WAS ADDITIONALLY PLACED AT THE JUNCTION PART IN THE DESCENDING AORTA. NO ENDOLEAK WAS CONFIRMED AND THE PROCEDURE WAS FINISHED. PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1750211 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E4051074 10827002448831

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Male Required Intervention