BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 9909215 · Received April 1, 2020

    Report

    Report Number
    3002808486-2020-00381
    Event Type
    Injury
    Date Received
    April 1, 2020
    Date of Event
    March 17, 2020
    Report Date
    December 9, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002353678
    PMA / PMN Number
    P140016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF#: (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A 66-YEAR-OLD MALE PATIENT UNDERWENT TEVAR WHERE A ZTA-P-42-173-W WAS INSERTED AROUND ZONE 2 IN THE AORTIC ARCH. THE ANATOMY WAS REPORTED TO BE VERY TORTUROUS. WHEN THE PHYSICIAN ROTATED THE HANDLE TO RELEASE THE STENT GRAFT, THE TIP ASSEMBLY CAME OFF AND STAYED ON THE WIRE END OF THE GRAFT. THE PHYSICIAN ADVANCED A LONGER AND LARGER SHEATH AND SNARED IT AROUND THE TIP ASSEMBLY TO REMOVE IT FROM THE PATIENT. THE ZTA DEVICE WAS RETURNED WITHOUT SHIPPING STYLET, STENT-GRAFT AND DISTAL PART OF THE INNER CANNULA TUBE. PER THE PRODUCT EVALUATION, THE CANNULA WAS FRACTURED. GLUE WAS FOUND IN THE PIN VISE. IT HAS NOT BEEN POSSIBLE TO DETERMINE WHY THE CANNULA WAS SEPARATED FROM THE PIN VISE. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE PRODUCT BEING PRODUCED OUT OF SPECIFICATION. IT HAS NOT BEEN POSSIBLE TO DETERMINE WHEN IN THE PROCESS THE CANNULA FRACTURED, HOWEVER, THE PRODUCT EVALUATION FOUND THAT THE ROUGHNESS OF THE FRACTURE INDICATED THAT THE FRACTURE OCCURRED OUTSIDE THE PATIENT. BASED ON THE PROVIDED INFORMATION AND EVALUATION OF THE RETURNED PRODUCT IT HAS NOT BEEN POSSIBLE TO ESTABLISH AN EXACT CAUSE FOR THE SEPARATION OF THE CANNULA FROM THE PIN VISE. IT WAS REPORTED THAT THE ANATOMY WAS TORTUOUS WHICH MIGHT HAVE CONTRIBUTED. 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

    MANUFACTURERS REF# (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A (B)(6) OLD MALE PATIENT UNDERWENT A TVAR PROCEDURE IN WHICH THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS, G35367, WAS USED. THE LAST GRAFT PIECE, (B)(4), WAS USED FOR BRIDGING BETWEEN TWO GRAFTS AS THE PROXIMAL GRAFT WAS TOO SHORT WITH THE DISTAL PIECE. WHEN THE PHYSICIAN FINISHED AND ROTATED THE DELIVERY SYSTEM THE NOSE CONE OF THE DEVICE INNER WHITE CANNULA CAME OFF AND STAYED ON THE WIRE END OF THE GRAFT. LEAVING THE NOSE CONE AND INNER CANNULA IN THE PATIENT. THE PHYSICIAN THEN ADVANCED A LONGER AND LARGER SHEATH AND SNARED THE SHEATH TO REMOVE FROM THE PATIENT. ADDITIONAL INFORMATION RECEIVED 20MAR2020: AFTER RELEASING THE STENT GRAFT, THE PHYSICIAN RETRIEVED THE INNER SYSTEM AND LEFT THE OUTER SHEATH IN ORDER TO PERFORM BALLOONING. WHEN THE INNER SYSTEM WAS TAKEN OUT, IT WAS NOTED THAT THE SYSTEM ONLY CONTAINED THE GREY POSITIONER ALONG WITH THE HANDLE AND THE TIP ASSEMBLY (DILATOR TIP AND CANNULA) WAS LEFT IN PATIENT. THERE WAS VERY TORTUROUS ANATOMY AND WE WERE WELL IN THE ARCH AROUND ZONE 2. SOME DIFFICULTY RETRIEVING DEVICE OVER THE ARCH BUT AS EXPECTED WITH THE ANATOMY AND SIZE OF ANEURYSM. PATIENT OUTCOME: 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
    374073 ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G35367 E3938709 10827002353678

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention