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

Model Number	G53452
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	10/15/2016
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.Secondary procedure done, alpha 38 x 167 implanted.On (b)(6) 2017: thoracic endograft (alpha 38x167).Right groin cutdown.Ultrasound-guided access of left common femoral artery.((b)(4)).On (b)(6) 2018: tevar re-lining distal dta between previous tevar and fenestrated endografts with 40x150mm gore ctag.((b)(4)).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.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4) investigation is still in progress.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
Description of event according to the initial reporter: component separation between zteg 2pt (42 to 38) and main body (36 prox).Implant procedure date (b)(6) 2015.Component separation (b)(6) 2016.(b)(6) 2017: thoracic endograft (alpha 38x167).Right groin cutdown.Ultrasound-guided access of left common femoral artery.(b)(4) (b)(6) 2018: tevar re-lining distal dta between previous tevar and fenestrated endografts with 40x150mm gore ctag.(b)(4) 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Summary of investigational findings: a patient underwent endovascular repair on (b)(6) 2015 where a zteg-2pt-42-158-pf-us (complaint device) and custom made branched device (cmd) were implanted.It was reported that follow-up ct on (b)(6) 2015 and (b)(6) 2015 revealed that there was almost no overlap between the tx2 and the cmd.On (b)(6) 2017 separation between the tx2 and cmd was found.On (b)(6) 2017 a secondary procedure was performed, and a zta-p-38-167-w was implanted between the tx2 and the cmd to treat the type 3a endoleak.X-ray from (b)(6) 2018 revealed that the zta and cmd had separated.Additional procedure was performed with a gore ctag to treat the separation between the zta and the cmd.This complaint is related to complaint (b)(4) (manufacturer ref#3002808486-2021-01889), zta-38-167-w, separation and type 3a endoleak.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 pre-procedure cta of (b)(6) 2015 moderate to severe tortuosity of the thoracic aorta was found and maximum thoracic aorta aneurysm diameter was 54.3 mm.On 4 days post-procedure cta of (b)(6) 2015 the following measurements were observed.The overlap between the tx2 and cmd was on bias (7.3/14.7 mm).Maximum thoracic aorta aneurysm diameter was 53.9 mm.The angulation at the overlap was 93.5-degrees.On the 2 year follow-up cta of (b)(6) 2017 the following measurements were observed, the overlap between the tx2 and cmd was 0 mm and type 3a endoleak was found, maximum thoracic aorta aneurysm diameter was 59.9 mm and the maximum localized aortic angulation (in area of zteg) was 112 ¿ degrees.As per clinical assessment the following was found: "it appears from the imaging that the tx2 was implanted with inadequate overlap.The junction between the two grafts ¿ the overlap region ¿ is right at the acute angulation of the supra-coeliac aorta.So, on the first imaging after implant, the two grafts are barely overlapping, with about a 1-stent overlap on the inner curvature (the concavity of the angulation), and a 4-5mm overlap at best on the external curvature (the convexity)." imaging from (b)(6) 2016 show "that the inevitable separation between the components occurred as would be expected, with the two grafts ¿angulating apart¿.There is a type 3 endoleak with extravasation of contrast." in the clinical assessment the imaging expert indicates that "the initial problem seems to be the lack of an adequate overlap on the primary procedure." according to the cmd drawing the proximal end of the cmd is about 50 mm before the first fenestration, this only allows a 2 stents overlap between the tx2 and cmd.The ifu states that the minimum required amount of overlap between devices is 2 stents (~50 mm), but recommend 3-4 stents overlap between devices.Angulation at the overlap between the tx2 and cmd 2 days post procedure was measured to 93.5-degrees.Device selection section (4.4) in the instructions for use which states: ¿landing the proximal and distal ends of the device in parallel aortic neck segments without acute angulation (>45 °) or circumferential thrombus/calcification is important to ensuring fixation and seal¿.Review of device history record gave no indication of the device being produced outside of specifications.Based on the provided information and findings in the images it is difficult to determine a single cause for the separation.The initial inadequate overlap between the tx2 and cmd and patient anatomy (large aneurysm and angulation) are potential contributing factors for the separation.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.

• 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: 12645617
• Report Number: 3002808486-2021-01882
• Device Sequence Number: 1376021
• Product Code: MIH
• UDI-Device Identifier: 10827002534527
• UDI-Public: (01)10827002534527(17)151109(10)E3005609
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 11/09/2015
• Device Model Number: G53452
• Device Catalogue Number: ZTEG-2PT-42-158-PF-US
• Device Lot Number: E3005609
• 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: 10/20/2021; 02/16/2022
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 10/25/2021; 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• 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