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

Model Number	G53432
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)
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: (b)(6)-year-old female with an extensive aneurysmal disease along with a chronically occluded celiac artery and a very tortuous aorta with a history of first stage elephant trunk repair underwent a successful staged endovascular taaa repair: thoracic stent and iliofemoral bypass placed on (b)(6) 2013 followed by custom 3-vessel branched stent graft and thoracic extension on (b)(6) 2013.On (b)(6) 2014, subject was seen with a large type iii endoleak between the thoracic extension and the main body stent grafts.This was successfully treated on (b)(6) 2014 by placing a tx2 zteg 36-202 as a bridge stent graft.The subject tolerated the procedure well.On (b)(6) 2014 the zteg-2p-34-152-pf-us and (b)(4) thoraco abdominal graft had separated.By report, the separation was bridged with a zteg-36-202 five days later.Implantation imaging or short term follow up was not provided.The patient reportedly presented three months later ((b)(6) 2014) with abdominal pain and was found to have a type iiia endoleak from zteg-36-202 and (b)(4) thoraco abdominal graft separation.The separations were the result of distal thoracic suprarenal abdominal aortic lengthening.Between 23sep2013 and 16may2014 this segment lengthened 26mm.Between 16may2014 and 10oct2014, the aorta lengthened 61mm.The lengthening is also subjectively evident in the increasing centerline tortuosity.Patient outcome: the subject expired on (b)(6) 2014 from complications of thoracic aneurysm rupture per death certificate.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Summary of investigational findings: this complaint is opened due to the following information in the imaging review from (b)(4); ¿the bridging zteg-36-202 also separated from the g38035fen thoraco abdominalgraft and resulted in a type iiia endoleak¿ the patient with an extensive aneurysmal disease along with a chronically occluded celiac artery and a very tortuous aorta with a history of first stage elephant trunk repair underwent a successful staged endovascular taaa repair: thoracic stent and iliofemoral bypass placed on (b)(6) 2013 followed by custom 3-vessel branched stent graft and thoracic extension on (b)(6) 2013.On (b)(6) 2014, subject was seen with a large type iii endoleak between the zteg-2p 34-152-pf-us and the main body stent grafts (b)(6).This was successfully treated on (b)(6) 2014 by placing a tx2 zteg 36-202 (complaint device) as a bridge stent graft.The subject tolerated the procedure well.The subject expired on (b)(6) 2014 from complications of thoracic aneurysm rupture per death certificate.¿ review of the device history record found that all discovered non-conformances were properly dispositioned before release.A pre-implantation cta, selected implantation angiography, and three follow-up ctas from (b)(6) 2012 and to (b)(6) 2014 were provided and reviewed by an imaging expert.Per the findings in the imaging review "the preimplantation cta demonstrates a thoraco-abdominal aneurysm downstream recent open ascending and arch replacement with an elephant trunk.The thoracic aorta was severely tortuous.Although a custom made bifurcated endograft and an inverted limb were specified, these were not implanted in favor of an aorta bi-femoral bypass." furthermore, "endograft separation was the result of distal thoracic suprarenal abdominal aortic lengthening.Between (b)(6) 2013 and (b)(6) 2014 this segment lengthened 26mm.Between (b)(6) 2015(this is assessed to be a typo from the imaging expert, as it is noted in the imaging review that images up until (b)(6) 2014 is provided and the patient expired on (b)(6) 2014.Therefore, 2015 should have been 2014) the aorta lengthened 61mm.The lengthening is also subjectively evident in the increasing centerline tortuosity." and "the patient¿s anatomy could not help to constrain the distal most thoracic aortic curve.Typically, the right diaphragm is higher than the left.Because of this, the distal most curve of the thoracic aorta enters the diaphragmatic crus at the liver.In this configuration, the liver prevents the aorta from bowing significantly across the midline from left to right.However, this patient¿s left diaphragm was even with and sometimes higher than the right.Consequently, the final aortic curve as it entered the crus could not be constrained by the liver.It had only lung, a gas filled compressible structure, to its right.This allowed the distal aortic curvature to increase without significant resistance across the midline into the right chest." based on these findings the imaging reviewers impressions are "the separations were the result of progressive distal thoracic and suprarenal abdominal aortic lengthening." based on the provided information and findings in the images the separation between the zteg and fenestrated device was related to patient anatomy, especially progressive aortic lengthening.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 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
• MDR Report Key: 13838826
• Report Number: 3002808486-2022-00193
• Device Sequence Number: 19082770
• Product Code: MIH
• UDI-Device Identifier: 10827002534329
• UDI-Public: (01)10827002534329(17)170114(10)E3172385
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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: 01/14/2017
• Device Model Number: G53432
• Device Catalogue Number: ZTEG-2P-36-202-PF-US
• Device Lot Number: E3172385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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: Death
• Patient Sex: Unknown