BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS

    MDR report key: 17682219 · Received September 5, 2023

    Report

    Report Number
    3002808486-2023-00232
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    February 15, 2023
    Report Date
    September 5, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002448831
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P140016. SUMMARY OF INVESTIGATIONAL FINDINGS: AFTER DEPLOYING ZTA-P-32-201-W1, ZTA-D-34-190-W1 (COMPLAINT DEVICE) WAS DELIVERED AND UNSHEATHED AT THE TARGET POSITION. THE NORMAL PROCEDURE WAS FOLLOWED, HOWEVER, WHEN THE INTRODUCTION SYSTEM AND THE SHEATH WAS CONNECTED UNTIL THE CLICK SOUND WAS HEARD TO RELEASE THE DISTAL BARE STENT, THE RELEASE WINDOW ON THE BLUE ROTATION HANDLE DID NOT TURN GREEN. THE DISTAL BARE STENT WAS RELEASED ANYWAY (RELATED COMPLAINT). AT THE END, THE HANDLE WAS TURNED TO RELEASE THE TRIGGER WIRE AT THE PROXIMAL, IT APPEARED THAT THE PROXIMAL PART OF THE STENT WAS STILL CLOSED UNDER FLUOROSCOPY. PER THE REPORTED INFORMATION, IT LOOKED LIKE THE PROXIMAL PART WAS SHUT FOR A WHILE AFTER THE INNER SHEATH WAS REMOVED, LIKE A SHAPE MEMORY. THE DOCTOR TRIED TO THINK OF A COUNTERMEASURE FOR ABOUT 5 MINUTES AND DELIVERED A BALLOON TO TOUCH UP, BUT THE PROXIMAL PART OF THE STENT GRAFT EXPANDED MORE THAN FIRST, AND THE PROCEDURE WAS FINISHED TAKING OUT THE SHEATH WITHOUT FURTHER PROBLEMS. AN ANGIOGRAPHY STUDY IS PROVIDED AND REVIEWED BY AN IMAGING EXPERT. PER THE IMAGING REVIEW, AFTER DEPLOYMENT OF THE ZTA-D COMPONENT, THE PROXIMAL ASPECT OF THE GRAFT REMAINS PARTIALLY CONSTRAINED AFTER FULL RELEASE. AFTER A SHORT TIME, THE PROXIMAL ASPECT SPONTANEOUSLY EXPANDS FULLY WITHOUT INTERVENTION. ALSO, PER THE IMAGING REVIEW, IT CANNOT BE DETERMINED FROM THE VERY LIMITED CONTRAST IMAGING, IF THIS ISSUE IS RELATED TO THE DEVICE OR OPERATOR TECHNIQUE. ZTA-D-34-190-W1 WAS RETURNED WITHOUT SHIPPING STYLET AND STENT GRAFT. DEVICE EVALUATION HAS BEEN PERFORMED. THE DEVICE EVALUATION SHOWED THAT THE DISTANCE BETWEEN THE SHORTEST AND THE LONGEST NITINOL WIRE WAS MEASURED AND WERE WITHIN SPECIFICATION. ADDITIONALLY, ALL ENDS OF ALL NITINOL WIRES WERE INSPECTED FOR BURRS OR INDENTATIONS AND NO ABNORMALITIES WERE OBSERVED. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. LATE EXPANSION OF THE PROXIMAL PART OF THE STENT GRAFT WAS CONFIRMED ON THE IMAGING REVIEW. HOWEVER, DUE TO VERY LIMITED CONTRAST IMAGING IT HAS NOT BEEN POSSIBLE TO DETERMINE A CONCLUSIVE CAUSE. THE DEVICE EVALUATION SHOWED NO NONCONFORMANCES ON THE DEVICE´S PARTS AND SHOWED THAT THE ROTATION HANDLE WAS ROTATED TO STOP AS PER THE INSTRUCTIONS FOR USE. BASED ON THE PROVIDED INFORMATION, DEVICE EVALUATION AND IMAGING REVIEW IT HAS NOT BEEN POSSIBLE TO DETERMINE THE CAUSE OF REPORTED EVENT. 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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A STENT GRAFT FROM ANOTHER MANUFACTURER HAD BEEN DEPLOYED FOR A TRUE ANEURYSM LOCATED AT THE LEVEL OF DIAPHRAGM IN (B)(6) 2021, HOWEVER THE ANEURYSM HAS BEEN ENLARGED TO 70MM IN DIAMETER DUE TO TYPE 1 OR TYPE 2 ENDOLEAK. THIS TIME, THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) WAS SCHEDULED TO DEPLOY ZTA-P-32-201-W1 FROM ZONE 4 AND FOLLOWED BY ZTA-D-34-190-W1 TO JUST ABOVE THE SUPERIOR MESENTERIC ARTERY (SMA) DUE TO DISTAL NECK (LANDING ZONE) SHORTAGE. THE MINIMUM ACCESS DIAMETER WAS 7.3MM AND NO PROBLEM. AFTER DEPLOYING ZTA-P-32-201-W1, ZTA-D-34-190-W1 WAS DELIVERED AND UNSHEATHED AT THE TARGET POSITION. THE NORMAL PROCEDURE WAS FOLLOWED, HOWEVER, WHEN THE INTRODUCTION SYSTEM AND THE SHEATH WAS CONNECTED UNTIL THE CLICK SOUND WAS HEARD TO RELEASE THE DISTAL BARE STENT, THE RELEASE WINDOW ON THE BLUE ROTATION HANDLE DID NOT TURN GREEN. THE DISTAL BARE STENT WAS RELEASED ANYWAY (B)(4). AT THE END, THE HANDLE WAS TURNED TO RELEASE THE TRIGGER WIRE AT THE PROXIMAL, IT APPEARED THAT THE PROXIMAL PART OF THE STENT WAS STILL CLOSED UNDER FLUOROSCOPY. WHILE WORKING OUT A COUNTERMEASURE FOR ABOUT 5 MINUTES, THE PROXIMAL PART EXPANDED AND THE PROCEDURE WAS FINISHED TAKING OUT THE SHEATH WITHOUT FURTHER PROBLEMS (THIS COMPLAINT). ADDITIONAL INFORMATION RECEIVED ON 21AUG2023: IMAGING REVIEWER FOUND A PERSISTENT FAINT ANTEGRADE PERFUSION TO THE CELIAC TRUNK DESPITE BEING COVERED BY THE ZTA-D DEVICE (B)(4), FDA REF# 3002808486-2023-00230). PATIENT OUTCOME: NO ADVERSE EFFECT ON THE PATIENT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170987 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E4338059 10827002448831

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening