BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT

    MDR report key: 12826158 · Received November 17, 2021

    Report

    Report Number
    3002808486-2021-01952
    Event Type
    Injury
    Date Received
    November 17, 2021
    Date of Event
    November 4, 2021
    Report Date
    April 20, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002474427
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF#:(B)(4). PMA/510(K): P180001. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: IT WAS REPORTED BY EMAIL THAT A 79-YEAR OLD FEMALE WITH A DISSECTION IN THORACIC AORTA UNDERWENT AN EMERGENCY THORACIC ENDOVASCULAR AORTIC REPAIR. A ZDEG-P-142-PF-US (COMPLAINT DEVICE) WAS USED IN THE PROCEDURE. IT WAS REPORTED, THAT THE GREEN TRIGGER WIRE MECHANISM WAS UNABLE TO BE REMOVED FROM THE DELIVERY SYSTEM. WHILE ATTEMPTING TO REMOVE THE GREEN TRIGGER WIRE FROM THE DELIVERY SYSTEM, THE GRAFT WAS INADVERTENTLY REPOSITIONED 1- 2 CM RESULTING IN AN INADEQUATE PROXIMAL LANDING. AS A RESULT, THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE (UNKNOWN STENT IMPLANTATION) TO PRESERVE CELIAC ARTERY. THE PATIENT EXPERIENCED NO ADVERSE EFFECT AFTER THE PROCEDURE. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. PER THE INSTRUCTIONS FOR USE SENT WITH THE DEVICE, THE GREEN TRIGGER WIRE KNOB SHOULD BE WITHDRAWN IN A CONTINUOUS MOVEMENT UNTIL THE PROXIMAL END OF THE GRAFT OPENS. THE GREEN TRIGGER WIRE KNOB SHOULD NOT BE ROTATED. THIS COMPLAINT IS BASED ON THE PROVIDED INFORMATION FROM CUSTOMER. NO IMAGING WAS AVAILABLE, OR PRODUCT WAS RETURNED. BASED ON THE PROVIDED INFORMATION, IT WAS NOT BE POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED FAILURE. 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). 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

    DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: POST DEPLOYMENT OF ZDEG, GREEN SLEEVE AND TRIGGER WIRES WOULD NOT RELEASE. EXCESSIVE FORCE REQUIRED TO RELEASE TRIGGER WIRES CAUSING DILATOR AND DEVICE TO MIGRATE DISTALLY RESULTING IN ENCROACHMENT OF THE CELIAC ARTERY. SUBSEQUENT STENT IMPLANTATION WAS REQUIRED TO PRESERVE CELIAC ARTERY. PATIENT OUTCOME: NO UNINTENDED DEVICE REMAINED INSIDE THE PATIENT´S BODY. THE PATIENT DID REQUIRE AN ADDITIONAL PROCEDURE DUE TO OCCURRENCE. A CELIAC COVERED STENT WAS PLACED TO PROTECT CELIAC FROM STENT MIGRATION AND MAL-PERFUSION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    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 27DEC2021: TRIGGER WIRES WERE RELEASED BY REMOVING THE TRIGGER WIRE RELEASE MECHANISM. PER DEPLOYMENT GUIDELINES THE SAFETY PIN WAS REMOVED AND THEN TRIGGER WIRE RELEASE MECHANISM WAS PULLED BUT DID NOT BUDGE. SAFETY WIRE RELEASE ¿GREEN SLEEVE¿ WAS ROTATED SLIGHTLY THEN REMOVED BY PULLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729882 ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G47442 E4079630 10827002474427

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention