BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS

    MDR report key: 9840705 · Received March 17, 2020

    Report

    Report Number
    3002808486-2020-00326
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    February 27, 2020
    Report Date
    February 3, 2021
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002449180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A MALE PATIENT WITH A SACCULAR ANEURYSM UNDERWENT TEVAR. IT WAS REPORTED THAT NO ANATOMICAL PROBLEMS WERE NOTED, HOWEVER THE TARGET SITE WAS SHORT WHY THE PHYSICIAN PLANNED TO USE A ZTA-DE-34-112-W1 (COMPLAINT DEVICE). IT WAS REPORTED THAT NO DEFORMATION OF THE SHEATH TIP WAS FOUND DURING PREPARATION OF THE DEVICE. WHEN INSERTING THE DEVICE INTO THE PATIENT¿S FEMORAL ARTERY, THE PHYSICIAN FELT RESISTANCE WHY THE DEVICE WAS REMOVED. UPON INSPECTION THE PHYSICIAN FOUND THAT THE SHEATH TIP WAS DEFORMED. THE PHYSICIAN REPLACED THE ZTA-DE-34-112-W1 WITH A ZTA-P-34-113-W1 AND WAS ABLE TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED. THE DEVICE WAS RETURNED WITHOUT SHIPPING STYLET. THE DEVICE WAS EVALUATED, AND DAMAGE WAS SEEN AT THE TIP OF THE FLEXOR SHEATH. BASED ON THE PRODUCT EVALUATION IT WAS NOT POSSIBLE TO DETERMINE A POSSIBLE CAUSE FOR THE DAMAGE. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE PRODUCT BEING PRODUCED OUT OF SPECIFICATION. THE INSTRUCTIONS FOR USE SENT WITH THIS DEVICE STATES "DO NOT CONTINUE ADVANCING THE WIRE GUIDE OR ANY PORTION OF THE INTRODUCTION SYSTEM IF RESISTANCE IS FELT. STOP AND ASSESS THE CAUSE OF RESISTANCE: VESSEL, CATHETER, OR GRAFT DAMAGE MAY OCCUR. EXERCISE PARTICULAR CARE IN AREAS OF STENOSIS, INTRAVASCULAR THROMBOSIS, OR CALCIFIED OR TORTUOUS VESSELS." BASED ON THE REPORTED INFORMATION AND EVALUATION OF THE RETURNED DEVICE, IT HAS NOT BEEN POSSIBLE TO ESTABLISH AN EXACT CAUSE FOR THIS EVENT. IT IS LIKELY THAT THE DAMAGE ON THE SHEATH TIP OCCURRED WHEN THE DEVICE WAS INSERTED INTO THE PATIENT ANATOMY AND RESISTANCE WAS FELT. 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

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). PMA/510K: SIMILAR TO DEVICE UNDER PMA P140016. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE ANATOMY WAS SUITABLE FOR THE PROCEDURE. NO ANATOMICAL PROBLEMS WERE NOTED. THE UNDERLYING DISEASE WAS SACCULAR ANEURYSM OF DESCENDING THORACIC AORTA, AND THE TARGET SITE WAS 30CM AND SHORT. FOR THIS REASON, THE PHYSICIAN PLANNED TO USE ZTA-DE-34-112-W1. WHEN INSERTING THE DELIVERY SYSTEM INTO THE PATIENT'S BODY FROM THE FEMORAL ARTERY, THE PHYSICIAN FELT RESISTANCE AND THAT THE DELIVERY SYSTEM WAS RUBBED LIGHTLY ON THE ACCESS ROUTE. THEN, HE REMOVED IT FROM THE PATIENT'S BODY, CONFIRMING THE SHEATH TIP WAS DEFORMED. THEREFORE, ZTA-P-34-113-W1 (E3807267) THAT IS THE SAME LENGTH AS THE COMPLAINT DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THE PHYSICIAN CONFIRMED BY ANGIOGRAPHY THAT THERE WERE NO DAMAGES AND ARTERY DISSECTION ON THE ACCESS ROUTE WHERE HE FELT RESISTANCE. PATIENT OUTCOME: NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304836 ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3853991 10827002449180

    Patients

    Seq Age Sex Outcome Treatment
    1