MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G35357
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	08/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Pma/510(k): p140016.Investigation is still in progress.
Event or Problem Description
Description of event according to the initial reporter: component separation.2yr celiac component separation.On (b)(6) 2018: type iii endoleak between the branch and tevar repaired with gore ctag 40x150 on (b)(6) 2018: component separation repair.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects 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: cook was notified of this event through an excel spreadsheet supplied by (b)(6) clinic.A patient underwent a evar (endovascular repair) on (b)(6) 2017, where a zta-p-38-117-w (complaint device) was implanted distally and a fen-thoraco-abdominal-graft (cmd) was implanted proximally.Ct dated (b)(6) 2017 revealed 2 stents overlap between zta and cmd device with overlap distance on 36,2mm.Ct dated (b)(6) 2017 revealed 2 stents overlap with overlap distance on 38,3mm.Ct dated (b)(6) 2018 revealed component separation with 0 mm overlap distance.Patient underwent a secondary intervention, where separation has been bridged with a gore stent graft.This complaint is related to wca complaint (b)(4) (component separation).Ctas and angiography from (b)(6) 2016 to (b)(6) 2018 were provided and reviewed for the investigation: on the pre-operative ct dated (b)(6) 2016 max.Thoracic aorta aneurysm diameter measured 43,8 mm; max.Abdominal aorta aneurysm diameter measured 58,5 mm.On the post-operative ct dated (b)(6) 2017 1,5 stents overlap measured 33,8mm between zta and cmd was revealed.Aortic angle of overlap measured 22,4 degrees.Max.Thoracic aorta aneurysm diameter measured 44,2 mm; max.Abdominal aorta aneurysm diameter measured 61,7mm.On the follow -up ct dated (b)(6) 2017 1,5 stents overlap measured 36,9mm - type 3 endolaek at sma stent/cmd overlap was revealed.Aortic angle of overlap measured 22,9 degrees.Max.Thoracic aorta aneurysm diameter measured 48,2 mm; max.Abdominal aorta aneurysm diameter measured 62,5 mm.On the follow-up ct dated (b)(6) 2017 1,5 stents overlap measured 37,2mm was observed.Aortic angle of overlap measured 24,5 degrees.Max.Thoracic aorta aneurysm diameter measured 52,1 mm; max.Abdominal aorta aneurysm diameter measured 62,3 mm.On the follow-up ct dated (b)(6) 2018 partial loss of overlap measured 13,1mm was observed.Aortic angle of overlap measured 58,5 degrees.Max.Thoracic aorta aneurysm diameter measured 57,2 mm; max.Abdominal aorta aneurysm diameter measured 63,7 mm.Input from cook global planning services provided that the evar components were planned by the customer physician.According to the fen-thoraco-abdominal-graft (cmd) drawing (refer to attached files) the proximal end of the cmd is about 62 mm before the first fenestration, this allows only 2 stents overlap between the zta and cmd.The ifu states that the minimum required amount of overlap between devices is 3 stents (~75 mm).Per the clinical assessment ¿the scans from that date, the (b)(6) 2017, show that an alpha thoracic graft has been inserted, along with a fenestrated cmd.The cmd has been ordered with only 2 stents above the coeliac fenestration, so the maximum overlap possible would have been 2 stents.The overlap in this case appears to be about 1.5 stents at most ¿ and this is only 8 days post-procedure¿.Also, per clinical assessment ¿the next image set is from 1 month later, on (b)(6) 2017.This confirms that the overlap is less than 2 stents.The next scan, from (b)(6) 2018 (almost a year later) is once again a non-contrast scan, and although difficult to assess, especially to produce static screensnips, there appears to be separation with the alpha graft being more tilted on an angle with this resulting in one side of the distal alpha graft having pulled out of the top of the cmd.We don¿t have any contrast images that would show any type 3 endoleak from the area of separation, but given that the grafts are not in contact with the aortic wall at that location, it would seem to be highly likely that a type 3 endoleak would have been present.The patient needed a secondary gore graft repair to bridge the separation gap, plus some re-stenting of the coeliac and sma bridging stents to repair the type 3 endoleak from the fenestration(s)¿.Review of the device history record gave no indication of the device being produced out of specification.Based on the provided information and clinical assessment it has not been possible to determine a single cause of the separation.The short overlap and large aneurysm are the possible causes of the reported event.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 ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• 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: 12645758
• Report Number: 3002808486-2021-01883
• Device Sequence Number: 20710986
• Product Code: MIH
• UDI-Device Identifier: 10827002353579
• UDI-Public: (01)10827002353579(17)191219(10)E3532351
• 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: 2017
• 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: 12/19/2019
• Device Model Number: G35357
• Device Catalogue Number: ZTA-P-38-117-W
• Device Lot Number: E3532351
• 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: 02/16/2022
• 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: 12/19/2016
• 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