MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G53450
Medical Device Problem Codes	Off-Label Use (1494); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Pma/510(k): unknown.Investigation is still in progress.
Event or Problem Description
Description of event according to the initial reporter: component separation.On (b)(6) 2016: index procedure: cook 4-vessel custom branched endograft with taa proximal extension (zteg, esbe and tbe).On (b)(6) 2020: component separation between the custom endograft and taa extension repaired with alpha ((b)(4)).On (b)(6) 2021: patient was transferred from an outside hospital with symptomatic taaa/separation of alpha graft from custom endograft due to other comorbidities, no intervention was performed ((b)(4)).
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Summary of investigational findings: a patient underwent endovascular repair on (b)(6) 2016 where a zteg-2pt-40-158-pf-us (complaint device) and custom made branched device (cmd) were implanted.The zteg device and the cmd separated, and it was reported that on (b)(6) 2020 a zta-p-40-167-w was implanted to treat the separation.On (b)(6) 2021, the patient was transferred from an outside hospital with symptomatic separation of zta from cmd, due to other comorbidities, no intervention was performed.The patient was discharged to home with blood pressure control.This complaint is related to wca complaint (b)(4) (branched cmd) and wce complaint (b)(4), (zta-p-40-167-w, separation).Ctas and angiography from (b)(6) 2015 and to (b)(6) 2021 including pre-procedure, post-procedure and follow-up imaging, and procedural angiography packages were provided for the investigation.On the 4 days post-procedure cta scan of (b)(6) 2016 the following was observed: the overlap between the zteg and cmd was 54.3 mm which is about 2.5 stent.The maximum thoracic aortic aneurysm diameter was 72.2 mm.Maximum localized aortic angulation in the area of the zteg was 51 degrees.The aortic angle at overlap was 0.4 degrees.On the follow-up cta scan of (b)(6) 2019 the following was observed: the overlap between the zteg and cmd was on bias (0/18 mm).The thoracic aortic aneurysm had a maximum diameter of 54.1 mm.The aortic angle at overlap was 123 degrees.As per clinical assessment, from the pre-procedure images on (b)(6) 2015 it was found that ¿just above the main component of the aneurysm, the aorta has a posterior kink¿.On (b)(6) 2016 a zteg, tbe and cmd device were implanted.4 days post-procedure imaging from (b)(6) 2016 showed ¿a 2.5 stent overlap between the tx2 distal end and the top end of the fen cmd.The tx2 was shown to be ¿folded¿ into the previously mentioned aortic kink to a degree." imaging from (b)(6) 2019 show ¿the development of an acute kink of the distal part of the tx2 graft.This has occurred at precisely the place where the kink was noted on the pre-op and subsequent scans.¿ and ¿the graft lumen is severely compromised almost to occlusion by the kinking of the tx2 graft.¿ on imaging from (b)(6) 2020 ¿the kinked graft has definitely separated from the top of the fen cmd, but only on the inner aspect of the kink." in the clinical assessment the imaging expert indicates that "i think the main problem with this case is the presence of the kink in the aorta, clearly visible on the initial imaging.While an initial good result appeared to have been achieved, the pressure of that kink on the endograft, apparently pushed the devices over towards the patient¿s right side inside the thoracic component of the aneurysm, eventually causing a graft kink of almost 90 degrees, an almost occluded lumen within the kink, and eventual separation of the inner aspect of the kink" and "i think it was just progression of the patient¿s pathology coupled with the hemodynamic forces associated with that kink in the aorta." maximum localized aortic angulation in the area of the zteg was 51 degrees on 4 days post-procedure imaging.The instructions for use states ¿landing the proximal and distal ends of the device in parallel aortic neck segments without acute angulation (>45°)¿ review of the device history record found that all discovered non-conformances were properly dispositioned before release and no indication that the device was produced outside of specification.Based on the provided information and findings in the images, patient anatomy and disease progression potentially contributed to the separation between the tx2 and cmd.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov ; 56868686
• MDR Report Key: 12645648
• Report Number: 3002808486-2021-01885
• Device Sequence Number: 19176479
• Product Code: MIH
• UDI-Device Identifier: 10827002534503
• UDI-Public: (01)10827002534503(17)170826(10)E3248656
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/26/2017
• Device Model Number: G53450
• Device Catalogue Number: ZTEG-2PT-40-158-PF-US
• Device Lot Number: E3248656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown