BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT

    MDR report key: 12914916 · Received December 2, 2021

    Report

    Report Number
    3002808486-2021-01981
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    August 3, 2021
    Report Date
    April 26, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). H6) ANNEX C22 = SIDE-EFFECT. SUMMARY OF INVESTIGATIONAL FINDINGS: 69-YEAR-OLD FEMALE WAS ENROLLED IN THE FRENCH REIMBURSEMENT STUDY AND HAD A TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) FOR A TYPE B DISSECTION. THE PRIMARY TEAR WAS DISTAL TO THE LEFT SUBCLAVIAN ARTERY AND THE DISTAL LOCATION WAS AT THE BILATERAL COMMON ILIAC ARTERIES. A ZDEG-PT-38-204-PF (COMPLAINT DEVICE) WAS IMPLANTED WITHOUT DIFFICULTY. THE DEGREE OF OVERSIZING WAS NOT REPORTED. NO MOLDING BALLOON WAS USED. ON 2-DAYS FOLLOW-UP CT ANGIO A RE-ENTRY/SECONDARY TEAR WAS OBSERVED (INITIALLY THOUGHT TO BE A TYPE V ENDOLEAK). THE RE-ENTRY TEAR WAS LOCATED ABOUT 5 CM DISTAL TO THE ZDEG. THE PATIENT WAS DISCHARGED ON (B)(6) 2021 WITH NO FURTHER INTERVENTION PLANS REPORTED. THE DEVICE WAS NOT RETURNED (IMPLANTED). NO PLANNING SIZE SHEETS WERE PROVIDED. AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION, COOK REVIEWED THE DEVICE MASTER RECORD CURRENTLY IN EFFECT FOR ZDEG DEVICES WHICH SHOWS ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. FURTHER, IT WAS NOT POSSIBLE TO CONDUCT A DEVICE HISTORY RECORD REVIEW DUE TO THE LACK OF LOT NUMBER. A CLINICAL ASSESSMENT WAS PERFORMED ON 25JAN2022. RELEVANT FINDINGS: CT ANGIO ON 03JUN2021 (PREOPERATIVE). THERE IS A TYPE B AORTIC DISSECTION FROM JUST DISTAL TO THE LSA (LEFT SUBCLAVIAN ARTERY) EXTENDING TO BILATERAL COMMON ILIAC ARTERIES. X-RAY ANGIO ON 18JUN2021 (OPERATION). FINAL AORTOGRAM SHOWS THE GRAFT IS PATENT. THERE IS FLOW INTO THE PROXIMAL LSA STUMP AT THE PROXIMAL GRAFT EDGE BUT NO ENDOLEAK AROUND THE GRAFT IS SEEN. THE DISTAL GRAFT IS SLIGHTLY COMPRESSED IN THE TRUE LUMEN COMPARED TO THE MID GRAFT AND NO ENDOLEAK IS SEEN DISTALLY. FALSE LUMEN FLOW ADJACENT TO THE ENDOGRAFT IS NOT CLEARLY SEEN. ABDOMINAL AORTOGRAM SHOWS THE DISTAL TA AND ABDOMINAL AORTA ARE PATENT WITH FAINT FALSE LUMEN FLOW AT THE VISCERAL SEGMENT OF THE ABDOMINAL AORTA. CT ANGIO ON 20JUN2021 (2 DAYS POSTOPERATIVE). THE MAXIMUM TA DIAMETER IS 47 MM AT THE MID SEGMENT. FALSE LUMEN PERFUSION IS SEEN FROM THE MID TO DISTAL GRAFT SEGMENT FROM RETROGRADE FLOW VIA A DISTAL RE-ENTRY TEAR ABOUT 27 MM DISTAL TO THE GRAFT EDGE. THE STUDY SITE HAD INITIALLY REPORTED A DISTAL TYPE V ENDOLEAK BUT THAT WAS UNCONFIRMED AND CHANGED TO BE A SECONDARY/RE-ENTRY TEAR LOCATED ABOUT 5 CM DISTAL TO THE ZDEG. THE IMAGING EXPERT HAD DESCRIBED A SECONDARY/RE-ENTRY TEAR LOCATED ¿27 MM DISTAL TO THE STENT GRAFT EDGE¿. PER ADDITIONAL INFORMATION, SPECIFICALLY REGARDING THE SECONDARY/RE-ENTRY TEAR, IT IS ASSESSED TO BE THE SAME TEAR. THERE IS NO DESCRIPTION ON THE PRE- OR PEROPERATIVE IMAGES BUT BECAUSE THE SECONDARY/RE-ENTRY TEAR WAS NOTED ONLY 2 DAYS AFTER THE PROCEDURE THIS COULD INDICATE A PROCEDURE-RELATED VESSEL WALL DAMAGE WHICH IS A KNOWN ADVERSE EVENT. THE IFU DESCRIBES ¿AORTIC DAMAGE, INCLUDING PERFORATION, DISSECTION, BLEEDING, RUPTURE AND DEATH¿ AS POTENTIAL ADVERSE EVENTS. NO DEVICE RELATED DIFFICULTIES WERE EXPERIENCED ACCORDING TO THE AVAILABLE INFORMATION. CONCLUSIVELY, IT WAS NOT POSSIBLE TO ESTABLISH AN EXACT CAUSE TO THE SECONDARY/RE-ENTRY TEAR. NO INFORMATION IS ASSESSED TO INDICATE A FAULT DEVICE. BASED ON THE PROVIDED INFORMATION THE EVENT SEEMS POSSIBLE TO HAVE OCCURRED DURING NORMAL USE OF THE DEVICE, HENCE CONSIDERED A SIDE-EFFECT INHERENT TO THE PROCEDURE. COOK WILL REOPEN THE INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. AFTER INVESTIGATION THE EVENT FOR THIS PR#347819 IS NO LONGER REPORTABLE. 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 INITIAL REPORTER: ON (B)(6) 2021 DURING THE INDEX PROCEDURE, A ZDEG-PT-38-204-PF (LOT# 2764286) WAS IMPLANTED WITHOUT DIFFICULTY. THE DEGREE OF OVERSIZING WAS NOT REPORTED. A MOLDING BALLOON WAS NOT USED DURING THE PROCEDURE. AND NO OTHER DEVICES WERE PLACED. PRIMARY INDICATION FOR IMPLANT WAS AN AORTIC DISSECTION. THE PRIMARY TEAR WAS DISTAL TO THE LEFT SUBCLAVIAN ARTERY. THE PROXIMAL LOCATION OF THE DISSECTION WAS WITHIN THE LEFT SUBCLAVIAN ARTERY AND THE DISTAL LOCATION WAS THE BILATERAL COMMON ILIAC ARTERIES. THERE WERE NO REPORTED RE-ENTRY TEARS. THE 18 MM PROXIMAL SEAL ZONE HAD NO TORTUOSITY, CALCIFICATION, OCCLUSIVE DISEASE OR THROMBUS. THE GRAFT FABRIC COMPLETELY COVERED THE LEFT SUBCLAVIAN ARTERY WHICH WAS REVASCULARIZED DURING THE IMPLANT PROCEDURE. THE DEVICE WAS PATENT WITHOUT DEVICE INTEGRITY ISSUES AT THE END OF THE PROCEDURE. CONTINUED FLOW INTO THE FALSE LUMEN THROUGH THE PRIMARY TEAR WAS REPORTED VIA A TYPE IB ENDOLEAK ((B)(4)). THE PATIENT WAS DISCHARGED ON (B)(6) 2021. A TYPE I DISTAL ENDOLEAK WAS REPORTED FOR THIS PATIENT ((B)(4)) ON THE PROCEDURE ANGIOGRAM. ON (B)(6) 2021 CT (46 DAYS POST-PROCEDURE), THE SITE REPORTED A TYPE V ENDOLEAK. ADDITIONAL INFORMATION RECEIVED 24NOV2021: THE TYPE V ENDOLEAK HAVE BEEN REMOVED FROM THE CLINICAL REPORT FORM AND REPORT THE FLOW TO THE FALSE LUMEN AS BEING FROM A SECONDARY TEAR AT THE ¿DISTAL THORACIC¿ ONLY. THE SITE, TO THIS POINT, HAS ONLY REPORTED A SECONDARY TEAR IN THE INFRARENAL AORTA. PATIENT OUTCOME: NO INTERVENTION PLANS HAVE BEEN REPORTED. 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
    1816640 ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Life Threatening