BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 5821291 · Received July 26, 2016

    Report

    Report Number
    3002808486-2016-00764
    Event Type
    Malfunction
    Date Received
    July 26, 2016
    Date of Event
    July 13, 2016
    Report Date
    July 13, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILARI TO DEVICE WITH 510(K) P070016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. SUMMARY OF INVESTIGATIONAL FINDINGS: THIS RECORD IS ABOUT A ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT, LOT E3453474. COMPLAINT IS RELATED TO A PATIENT WHOSE EXHIBITED PURPURA, CHANGE IN COLOR AND PAIN IN A LEG AND LOWER LEG. A BIOPSY OF THE AFFECTED AREA WAS CONDUCTED AND THE PHYSICIAN SUSPECTED IT WAS DUE TO HYDROPHILIC POLYMER EMBOLI FROM THE BIOPSY RESULT. NO ADDITIONAL PROCEDURE WAS CONDUCTED TO TREAT THE SYMPTOMS BUT THE SYMPTOMS WERE IMPROVING. THE SHEATH OF THE DELIVERY SYSTEM FOR THIS PRODUCT IS HYDROPHOBICALLY COATED. NO EVIDENCE WAS FOUND TO SUPPORT THAT THE DEVICE WAS MANUFACTURED OUTSIDE COOK MEDICAL SPECIFICATIONS. HOWEVER, SINCE THE DEVICE WAS NOT RETURNED, A DEEPER EVALUATION COULD NOT BE PERFORMED. AFTER EVALUATION, NO OBJECTIVE EVIDENCE WAS FOUND TO DETERMINE IF THIS EVENT WAS PROCEDURAL, PATIENT OR DEVICE RELATED, HOWEVER, A CAPA HAS BEEN RAISED FOR SIMILAR EVENTS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: A (B)(6) MALE PATIENT UNDERWENT TAA REPAIR. THE PATIENT ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR. ON (B)(6) 2016: ELEPHANT TRUNK WAS PREVIOUSLY PLACED IN THE ASCENDING AORTA. ON (B)(6) 2016: ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT WAS PLACED AS LABELED. ON (B)(6) 2016: PURPURA, CHANGE IN COLOR AND PAIN IN A LEG AND LOWER LEG WERE CONFIRMED. BIOPSY OF THE AFFECTED AREA WAS CONDUCTED AND THE PHYSICIAN SUSPECTED IT WAS DUE TO HYDROPHILIC POLYMER EMBOLI FROM THE BIOPSY RESULT. GORE'S DRYSEAL SHEATH WITH HYDROPHILIC COATING AND A BALLOON CATHETER WERE ALSO USED FOR THIS PROCEDURE. PATIENT OUTCOME: NO ADDITIONAL PROCEDURE WAS CONDUCTED TO TREAT THE SYMPTOMS BUT THE SYMPTOMS ARE IMPROVING.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A (B)(6) MALE PATIENT UNDERWENT TAA REPAIR. THE PATIENT ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR. ON (B)(6) 2016: ELEPHANT TRUNK WAS PREVIOUSLY PLACED IN THE ASCENDING AORTA. ON (B)(6) 2016: ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT WAS PLACED AS LABELED. ON (B)(6) 2016: PURPURA, CHANGE IN COLOR AND PAIN IN A LEG AND LOWER LEG WERE CONFIRMED. BIOPSY OF THE AFFECTED AREA WAS CONDUCTED AND THE PHYSICIAN SUSPECTED IT WAS DUE TO HYDROPHILIC POLYMER EMBOLI FROM THE BIOPSY RESULT. GORE'S DRYSEAL SHEATH WITH HYDROPHILIC COATING AND A BALLOON CATHETER WERE ALSO USED FOR THIS PROCEDURE. PATIENT OUTCOME: NO ADDITIONAL PROCEDURE WAS CONDUCTED TO TREAT THE SYMPTOMS BUT THE SYMPTOMS ARE IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476187 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526959

    Patients

    Seq Age Sex Outcome Treatment
    1 Other