BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 12354637 · Received August 23, 2021

    Report

    Report Number
    3002808486-2021-01751
    Event Type
    Injury
    Date Received
    August 23, 2021
    Date of Event
    August 18, 2021
    Report Date
    February 22, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002449593
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A 78-YEAR-OLD MALE PATIENT WITH AN ANEURYSM IN THE THORACIC AORTA UNDERWENT A TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR), WHERE A ZTA-P-36-209-W1 (COMPLAINT DEVICE) WAS IMPLANTED PROXIMALLY AND A ZTA-D-28-160-W1 WAS IMPLANTED DISTALLY. A TYPE 1A ENDOLEAK WAS REVEALED. THE PHYSICIAN PLANNED TO USE A ZTA-DE-34-112-W1 TO RESOLVE THE ENDOLEAK. DURING THE PREPARATION IT WAS NOT POSSIBLE TO FLUSH THE ZTA-DE-34-112-W1 ((B)(4)). IT WAS REPORTED THAT THE ENDOLEAK HAD BEEN ALMOST GONE AND THE PHYSICIAN DECIDED TO COMPLETE THE PROCEDURE WITHOUT USING THE ZTA-DE-34-112-W1. NO ADVERSE EFFECTS TO PATIENT HAVE BEEN REPORTED. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. PER THE INSTRUCTIONS FOR USE (IFU) ENDOLEAK IS A KNOWN POTENTIAL ADVERSE EVENT. ALSO, PER IFU, THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ANEURYSMS OR ULCERS OF THE DESCENDING THORACIC AORTA HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR INCLUDING NONANEURYSMAL AORTIC SEGMENTS (FIXATION SITES) PROXIMAL AND DISTAL TO THE THORACIC ANEURYSM OR ULCER WITH A LENGTH OF AT LEAST 20 MM, AND WITH A DIAMETER MEASURED OUTER-WALL-TO-OUTER-WALL OF NO GREATER THAN 42 MM AND NO LESS THAN 20 MM. NO IMAGING AND NO PLANNING SHEET WERE PROVIDED. BASED ON THE PROVIDED INFORMATION IT HAS NOT BEEN POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. 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). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P140016. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORTER: A (B)(6) MALE PATIENT UNDERWENT TAA REPAIR. THE USER PLACED ZTA-P-36-209-W1 IN THE PROXIMAL SIDE AND ZTA-D-28-160-W1 IN THE DISTAL SIDE OF THE DESCENDING AORTA. THEN PROXIMAL TYPE I ENDOLEAK WAS CONFIRMED. ((B)(4)) TO TREAT THIS ENDOLEAK, THE USER PLANNED TO PLACE ZTA-DE-34-112-W1 IN THE PROXIMAL SIDE OF ZTA-P-36-209-W1, HE OPENED THE PACKAGE AND FLUSHED THE DELIVERY SYSTEM SEVERAL TIMES BUT THE FLUSHING FLUID DIDN'T COME OUT FROM THE DISTAL SIDE. AIR COULD NOT BE REMOVED. ((B)(4)) FORTUNATELY, THE ENDOLEAK HAD BEEN ALMOST GONE SO THE USER DECIDED NOT TO PLACE ANY DEVICES TO TREAT ENDOLEAK AND COMPLETED THE PROCEDURE. THE PATIENT WILL BE CLOSELY FOLLOWED. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250913 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3846121 10827002449593

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male