BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT

    MDR report key: 13768106 · Received March 15, 2022

    Report

    Report Number
    3002808486-2022-00192
    Event Type
    Injury
    Date Received
    March 15, 2022
    Date of Event
    July 2, 2021
    Report Date
    August 4, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002242842
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P180001. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). AFTER INVESTIGATION THE EVENT FOR (B)(4) IS NO LONGER REPORTABLE. H6) C22 - APPROPRIATE TERM/CODE NOT AVAILABLE FOR SIDE EFFECT. SUMMARY OF INVESTIGATIONAL FINDINGS: A 71-YEAR OLD MALE PATIENT WHO WAS ENROLLED IN FRENCH REIMBURSEMENT STUDY UNDERWENT ENDOVASCULAR AORTIC REPAIR ON (B)(6) 2021, WHERE A ZDEG-P-36-204-PF (COMPLAINT DEVICE). THE DEGREE OF OVERSIZING WAS NOT REPORTED. A BENTLY 6 X 58 STENT WAS IMPLANTED INTO THE RIGHT RENAL ARTERY DUE TO POOR PERFUSION FROM THE FALSE LUMEN. PRIMARY INDICATION WAS AN ACUTE TYPE B DISSECTION WITH A THORACIC ANEURYSM COMPLICATED BY A HEMOTHORAX AND HYPOTENSION 80/60MMHG. THE PRIMARY TEAR AND THE PROXIMAL LOCATION OF THE DISSECTION WAS IN THE DESCENDING AORTA, DISTAL TO THE LEFT SUBCLAVIAN ARTERY. THE DISTAL LOCATION WAS THE AORTA AT THE CELIAC ARTERY (QUERY HAS BEEN PLACED TO CLARIFY SINCE THE FALSE LUMEN WAS ALSO REPORTED TO AFFECT THE RIGHT RENAL ARTERY). THERE WERE NO REPORTED RE-ENTRY TEARS. TORTUOSITY, OCCLUSIVE DISEASE, CALCIFICATION, AND THROMBUS WITHIN THE PROXIMAL LANDING ZONE WERE NOT ABLE TO BE ASSESSED. THE GRAFT FABRIC DID NOT COVER THE LEFT SUBCLAVIAN ARTERY. THE DEVICE WAS PATENT WITHOUT DEVICE INTEGRITY ISSUES AND THE FALSE LUMEN WAS COMPLETELY THROMBOSED AT THE END OF THE PROCEDURE. ON (B)(6) 2021 (6 DAYS POST-PROCEDURE), A CT REVEALED A TYPE 1A ENDOLEAK. NO DEVICE INTEGRITY ISSUES, SEPARATION OF STUDY DEVICES OR MIGRATION WERE REPORTED. ON (B)(6) 2021 (11 DAYS POST-PROCEDURE), A SECONDARY INTERVENTION WITH A PROXIMAL GRAFT EXTENSION, A CAROTID-SUBCLAVIAN BYPASS, AND COIL EMBOLIZATION OF THE LEFT SUBCLAVIAN ARTERY HAVE BEEN PERFORMED. THE SECONDARY INTERVENTION HAS BEEN REPORTED TO BE SUCCESSFUL. ON (B)(6) 2021 (170 DAYS POST-PROCEDURE), A CT REVEALED THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED. THE ABDOMINAL FALSE LUMEN WAS PARTIALLY THROMBOSED WITH FALSE LUMEN PERFUSION FROM A SECONDARY TEAR AT THE AORTIC BIFURCATION. THE PREOP CT DATED (B)(6) 2021 AND THE 6-DAY POSTOP CT DATED (B)(6) 2021 WERE PROVIDED AND REVIEWED BY AN IMAGING EXPERT. THE 6-DAY POSTOP CT STUDY IS OF LIMITED QUALITY WITH POOR ENHANCEMENT. PER THE FINDINGS IN THE IMAGING REVIEW, THE PROXIMAL ZDEG (36 X 204 MM) GRAFT BEGINS 8 MM PAST THE LSA. THE AORTIC DIAMETER AT THE LSA IS 40 MM INCLUDING THE FALSE LUMEN. IT IS UNCLEAR IF THERE IS ANY FALSE LUMEN PERFUSION AROUND THE ZDEG GRAFT DUE TO POOR ENHANCEMENT. THERE IS A THIN RIM OF CONTRAST AROUND THE PROXIMAL TO MID ZDEG THAT APPEARS TO BE CONFINED WITHIN THE TRUE LUMEN AND COMMUNICATES WITH INTERCOSTAL BRANCHES, CONSISTENT WITH A TYPE 2 OR TYPE 1A ENDOLEAK. PER THE IMPRESSIONS IN THE IMAGING REVIEW, BASED ON THE CURRENT STUDY, THIS MOST LIKELY APPEARS TO BE A LIMITED TYPE 2 ENDOLEAK FROM INTERCOSTAL BRANCHES. ALSO, PER THE IMPRESSIONS IN THE IMAGING REVIEW, ON THE PREOP STUDY, THE TOTAL AORTIC DIAMETER IS 39 MM WITH A TRUE LUMEN DIAMETER OF 29 MM. THE 36 MM DEVICE IS APPROPRIATELY SIZED FOR THE TRUE LUMEN BUT COULD BE UNDERSIZED BASED ON THE TOTAL AORTIC DIAMETER, WHICH COULD RESULT IN A TYPE 1A ENDOLEAK IF THE FALSE LUMEN COLLAPSES COMPLETELY AND THE TRUE LUMEN EXPANDS. THERE IS EXPANSION OF THE PROXIMAL AORTA FROM 64 MM TO 70 MM AT 6 DAYS, SO THERE COULD BE CONCOMITANT EXPANSION OF THE TRUE LUMEN TO A DIAMETER LARGER THAN THE NOMINAL DIAMETER OF THE GRAFT (36 MM), RESULTING IN A TYPE 1A ENDOLEAK. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. PER THE INSTRUCTIONS FOR USE, ENDOLEAK IS A KNOWN POTENTIAL ADVERSE EVENT. BASED ON THE PROVIDED INFORMATION AND THE IMAGING REVIEW IT HAS NOT BEEN POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. DUE TO LIMITED QUALITY OF THE PROVIDED IMAGING, THE TYPE OF ENDOLEAK IS UNCLEAR, BUT MOST LIKELY APPEARS TO BE A LIMITED TYPE 2 ENDOLEAK FROM INTERCOSTAL BRANCHES. COOK WILL REOPEN THIS COMPLAINT IF ADDITIONAL INFORMATION WILL BE PROVIDED. 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 INITIAL REPORTER: ON (B)(6) 2021, DURING THE INDEX PROCEDURE, A ZDEG-P-36-204-PF (LOT# E4055854) WAS IMPLANTED WITHOUT DIFFICULTY. THE DEGREE OF OVERSIZING WAS NOT REPORTED. A BENTLY 6 X 58 STENT WAS IMPLANTED INTO THE RIGHT RENAL ARTERY DUE TO POOR PERFUSION FROM THE FALSE LUMEN. PRIMARY INDICATION FOR IMPLANT WAS AN ¿ACUTE TYPE B DISSECTION WITH A THORACIC ANEURYSM COMPLICATED BY A HEMOTHORAX AND HYPOTENSION 80/60MMHG¿. THE PRIMARY TEAR AND THE PROXIMAL LOCATION OF THE DISSECTION WAS IN THE DESCENDING AORTA, DISTAL TO THE LEFT SUBCLAVIAN ARTERY. THE DISTAL LOCATION WAS THE AORTA AT THE CELIAC ARTERY (QUERY HAS BEEN PLACED TO CLARIFY SINCE THE FALSE LUMEN WAS ALSO REPORTED TO AFFECT THE RIGHT RENAL ARTERY). THERE WERE NO REPORTED RE-ENTRY TEARS. TORTUOSITY, OCCLUSIVE DISEASE, CALCIFICATION AND THROMBUS WITHIN THE PROXIMAL LANDING ZONE WERE NOT ABLE TO BE ASSESSED. THE GRAFT FABRIC DID NOT COVER THE LEFT SUBCLAVIAN ARTERY. THE DEVICE WAS PATENT WITHOUT DEVICE INTEGRITY ISSUES AND THE FALSE LUMEN WAS COMPLETELY THROMBOSED AT THE END OF THE PROCEDURE. ON (B)(6) 2021 (6 DAYS POST-PROCEDURE), A CT REVEALED A TYPE IA (PROXIMAL) ENDOLEAK. NO DEVICE INTEGRITY ISSUES, SEPARATION OF STUDY DEVICES OR MIGRATION WERE REPORTED. ON (B)(6) 2021 (11 DAYS POST-PROCEDURE), A SECONDARY INTERVENTION WAS COMPLETED TO PLACE A PROXIMAL GRAFT EXTENSION (DEVICE INFORMATION NOT PROVIDED), COMPLETE A CAROTID-SUBCLAVIAN BYPASS, AND COIL EMBOLIZATION OF THE LEFT SUBCLAVIAN ARTERY. THE SECONDARY INTERVENTION WAS REPORTED TO BE SUCCESSFUL. THE PATIENT WAS DISCHARGED ON (B)(6) 2021. ON (B)(6) 2021 (69 DAYS POST-PROCEDURE), A CT REVEALED THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED. NO DEVICE INTEGRITY ISSUES, SEPARATION OF STUDY DEVICES OR MIGRATION WERE REPORTED. ON (B)(6) 2021 (170 DAYS POST-PROCEDURE), A CT REVEALED THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED. THE ABDOMINAL FALSE LUMEN WAS PARTIALLY THROMBOSED WITH FALSE LUMEN PERFUSION FROM A SECONDARY TEAR AT THE AORTIC BIFURCATION. NO DEVICE INTEGRITY ISSUES, SEPARATION OF STUDY DEVICES OR MIGRATION WERE REPORTED. PATIENT OUTCOME: THE ENDOLEAK RESOLVED AFTER SECONDARY INTERVENTION. THE PATIENT REMAINS IN THE STUDY.

    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
    601845 ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E4055854 10827002242842

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Life Threatening