BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS

    MDR report key: 19880999 · Received August 1, 2024

    Report

    Report Number
    3002808486-2024-00144
    Event Type
    Injury
    Date Received
    August 1, 2024
    Date of Event
    January 28, 2023
    Report Date
    November 12, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002346595
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: ENDOLEAK TYPE IA NOTED DURING FOLLOW-UP. TREATED BY SECONDARY INTERVENTION/ADDITIONAL GRAFT(S) PLACED AND RESOLVED WITHOUT SEQUELAE. DESPITE EFFORTS TO OBTAIN CLARIFICATION AND ADDITIONAL INFORMATION THIS WAS NOT PROVIDED. THEREFORE, BASED ON THE INFORMATION PROVIDED, IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY HAVE NOT CAUSED THE ENDOLEAK TYPE IA. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. IT IS ASSESSED THAT BECAUSE NO NON-CONFORMANCES WERE DETECTED THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN COMPLIANCE WITH PROCEDURES AND ACCORDING TO SPECIFICATIONS. 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 STUDY: FROM FOLLOW-UP CT/MRI, ENDOLEAKS: TYPE I = YES. PROXIMAL IS THERE EVIDENCE OF DEVICE ISSUE(S)? = NO PATIENT OUTCOME: WAS A NEW SECONDARY INTERVENTION PERFORMED TO TREAT THE ENDOLEAK(S)? = YES. ADDITIONAL GRAFT(S) PLACED AND BALLOON ANGIOPLASTY RESOLVED (PATIENT RECOVERED/STABILIZED) WITHOUT SEQUELAE.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164710 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G34659 E4327233 10827002346595

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention