BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT

    MDR report key: 17222935 · Received June 29, 2023

    Report

    Report Number
    3002808486-2023-00184
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    May 30, 2023
    Report Date
    October 12, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002242781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A MALE PATIENT WAS TREATED USING A ZDEG-P-34-154-PF. IT IS REPORTED THAT THE ENDOGRAFT WAS VERY DIFFICULT TO RELEASE. IT SEEMS LIKE IT WAS STUCK IN THE SHEATH AS IS IT WAS A LONG STANDING DEVICE. THE USER HAD NO PROBLEMS OF NAVIGATION RELATED TO VESSELS TORTUOSITY. PER ADDITIONAL INFORMATION REPORTED IT WAS BOTH DIFFICULT TO WITHDRAW THE SHEATH ((B)(4), REF# 3002808486-2023-00247) AND DIFFICULT TO PULL THE TRIGGER WIRES (THIS COMPLAINT). NO EVIDENT TORTUOSITY OF THE AORTA WAS DETECTED DURING THE PROCEDURE. THE DEVICE LANDED AS PLANNED AND NO ADVERSE EFFECTS TO THE PATIENT ARE REPORTED. NO EVIDENCE TO SUGGEST THAT THE PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION AND NO PROCEDURAL IMAGES ARE PROVIDED. BASED ON THE PROVIDED INFORMATION IT HAS NOT BEEN POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED DIFFICULTIES WITH WITHDRAWING THE TRIGGER WIRE MECHANISM. 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.

    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): P180001. INVESTIGATION IS STILL IN PROGRESS. 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.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ACCORDING TO THE DOCTOR, IT WAS VERY DIFFICULT TO USE THE DEVICE DURING THE PROCEDURE. THE ENDOGRAFT WAS VERY DIFFICULT TO RELEASE. IT SEEMS LIKE IT WAS STUCK IN THE SHEATH AS IS IT WAS A LONG STANDING DEVICE. THE DOCTORS HAD NO PROBLEMS OF NAVIGATION RELATED TO VESSELS TORTUOSITY. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562432 ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E4357951 10827002242781

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male