BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS

    MDR report key: 19849804 · Received July 29, 2024

    Report

    Report Number
    3002808486-2024-00136
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    September 3, 2019
    Report Date
    November 21, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002346519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). G4) 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

    MANUFACTURER REF# (B)(4). AFTER INVESTIGATION THE EVENT IS NO LONGER CONSIDERED REPORTABLE. H6) C22 - APPROPRIATE TERM/CODE NOT AVAILABLE FOR SIDE-EFFECT D17 - APPROPRIATE TERM/CODE NOT AVAILABLE FOR SIDE-EFFECT SUMMARY OF INVESTIGATIONAL FINDINGS: ENDOLEAK TYPE 1B AT COMPLETION OF PROCEDURE, BUT NO ENDOLEAK NOTED FOR ONE MONTH AND 1-YEAR FOLLOW-UP. IT IS NOTED THAT THE ENDOLEAK RESOLVED AND THAT NO TREATMENT/SECONDARY INTERVENTION WAS REQUIRED. COMBINED WITH THE FACTS THAT THE DISTAL NECK REPORTEDLY HAD ¿IRREGULAR SHAPE¿ AS WELL AS ¿MODERATE TORTUOSITY¿ AND THE PATIENT WAS TREATED WITH ANTICOAGULANTS, THE ENDOLEAK IS CONSIDERED OF NO FAULT TO THE DEVICE. THE REPORTED PROCEDURE-RELATED ENDOLEAK IS ASSESSED TO BE AN INHERENT SIDE-EFFECT TO THE PROCEDURE. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. IT IS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE QC RELEASE, 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 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 STUDY: PROCEDURE INFORMATION: DATE OF PROCEDURE = (B)(6) 2019. PROCEDURE ANGIOGRAPHY, ENDOLEAKS: IS THERE EVIDENCE OF ENDOLEAK(S) AT THE COMPLETION OF PROCEDURE? YES. TYPE I = YES. IF TYPE I, INDICATE TYPE(S): TYPE IB (DISTAL) . WAS A NEW SECONDARY INTERVENTION PERFORMED TO TREAT THE ENDOLEAK(S)? NO. THERE IS NO TREATMENT OR OUTCOME INFORMATION COLLECTED ON THE PAGE. PROCEDURE ANGIOGRAPHY, DEVICE ASSESSMENT: IS THERE EVIDENCE OF DEVICE ISSUE(S) AT THE COMPLETION OF PROCEDURE? NO. FOLLOW-UP CT/MRI, ENDOLEAKS FOR: 1-MONTH FOLLOW-UP VISIT IS THERE EVIDENCE OF ENDOLEAK(S)? NO. FOLLOW-UP CT/MRI FOR: 12-MONTH FOLLOW-UP VISIT IS THERE EVIDENCE OF ENDOLEAK(S)? NO.

    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
    384343 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3783665 10827002346519

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male