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

Catalog Number ZTA-P-30-155

Device Problems Off-Label Use (1494); Material Separation (1562); Patient Device Interaction Problem (4001)

Patient Problems Vascular Dissection (3160); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Similar to device marketed under p140016.Investigation is still in progress.This report is required by the fda under 21cfr 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 Description

Description of event according to initial reporter: suspected type 3 endoleak, either at fenestration or between cmd graft and zta graft.Patient outcome: no adverse effect on the patient was reported due to this occurrence.

Manufacturer Narrative

Manufacturer ref# (b)(4).The investigation has been updated due to update from imaging reviewer.Summary of investigational findings: per the reported information a type 3 endoleak has been suspected either at fenestration or between a thoracic-prox-fen (cmd graft) and a zta-p-30-155 (complaint device).According to the imaging review, an endoleak involving the zta was not confirmed.The reported endoleak involved the cmd.The imaging review revealed a sine at the zta¿s distal end.Treatment in form of open repair is being planned.Planning and sizing worksheet 3d and centerline reconstruction images from a 10oct2017 preimplantation cta and a follow-up cta 18jul2022 were provided along with the complaint report.Additionally photographs and engineering drawings of the cmd were provided.These have been reviewed by an imaging expert.Per the imaging review "over the ensuing five years, a stent graft induced entry tear (sine) accompanied by 67mm of aortic elongation developed at the end of the zta-p.The resulting retrograde false lumen perfusion was not an endoleak because it was between the true intimal and false lumen rather than the zta-p and the true lumen intima.The proximal thoracic pseudoaneurysm had enlarged but was relatively separated from the sine.Per the imaging reviewers impression ¿distal thoracic aortic aneurysmal false lumen perfusion at the distal zta-p was secondary to a sine at the zta¿s distal end rather than an endoleak¿.Inquired the imaging reviewer informs that the dissected intima is particularly brittle.Additionally, he informs that the dissection extends to the iliac arteries and that the sine has made the dissection worse as it exposes the false lumen to greater pressure.Open repair treatment was planned to treat the dissection.It is assumed that sine will also be treated under the same procedure.Review of the device history record gave no indication of the device being produced out of specification.There were no indications on fault device.It is difficult to determine a conclusive cause for a sine.However, patient condition might be a possible contributing factor.It is noticed that zta device is used for treatment of dissection which is outside of intended use.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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: per the reported information a type 3 endoleak has been suspected either at fenestration or between a thoracic-prox-fen (cmd graft) and a zta-p-30-155 (complaint device).According to the imaging review, an endoleak involving the zta was not confirmed.The reported endoleak involved the cmd.The imaging review revealed a sine at the zta¿s distal end.Treatment in form of open repair is being planned.Planning and sizing worksheet 3d and centerline reconstruction images from a 10oct2017 preimplantation cta and a follow-up cta (b)(6) 2022 were provided along with the complaint report.Additionally photographs and engineering drawings of the cmd were provided.These have been reviewed by an imaging expert.Per the imaging review "over the ensuing five years, a stent graft induced entry tear (sine) accompanied by 67mm of aortic elongation developed at the end of the zta-p.The resulting retrograde false lumen perfusion was not an endoleak because it was between the true intimal and false lumen rather than the zta-p and the true lumen intima.The proximal thoracic pseudoaneurysm had enlarged but was relatively separated from the sine.Per the imaging reviewers impression ¿distal thoracic aortic aneurysmal false lumen perfusion at the distal zta-p was secondary to a sine at the zta¿s distal end rather than an endoleak¿.Inquired the imaging reviewer informs that the dissected intima is particularly brittle.Additionally, he informs that the dissection extends to the iliac arteries.However, pre-implantation images are to limited to determine whether sine could have contributed to the abdominal dissection.Open repair treatment was planned to treat the dissection.It is assumed that sine will also be treated under the same procedure.Review of the device history record gave no indication of the device being produced out of specification.There were no indications on fault device.It is difficult to determine a conclusive cause for a sine.However, patient condition might be a possible contributing factor.It is noticed that zta device is used for treatment of dissection which is outside of intended use.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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• Type of Device: 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: 15182578
• MDR Text Key: 304963370
• Report Number: 3002808486-2022-00916
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002346878
• UDI-Public: (01)10827002346878(17)200308(10)E3560067
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2020
• Device Catalogue Number: ZTA-P-30-155
• Device Lot Number: E3560067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/08/2022
• Supplement Dates Manufacturer Received: 11/01/2022; 11/09/2022
• Supplement Dates FDA Received: 11/04/2022; 11/10/2022
• Date Device Manufactured: 03/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1