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-34-209-W1

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Rupture (2208); Cardiac Tamponade (2226)

Event Date 09/28/2023

Event Type  Death  

Manufacturer Narrative

Manufacturers ref# (b)(4).G4) similar to device marketed under pma/510(k): 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: primary disease: aneurysm of thoracic aorta.Devices used: zta-p-34-209-w1(lot# e4399562) approached from the right femoral artery to the thoracic aorta.Zta-p-32-201-w1(lot# e4326558) approached from the right femoral artery to the thoracic aorta.Balloon catheter from another manufacturer.Procedure: normal thoracic endo vascular aortic repair (tevar).There was some off-label use: fenestration was performed for the left subclavian artery.Tevar was performed for extensive thoracic aortic aneurysm using alpha thoracic.Because of the need to place a stent graft from zone 2 and due to shaggy aorta anatomically, bypass was avoided by performing a left subclavian artery fenestration of site's own making.After zta-p-32-201-w1 was deployed at distal, zta-p-34-209-w1 was piled up and deployed, and contrast was performed.There was calcification in the proximal landing area and risk of an endoleak.As expected, a type ia endoleak occurred, so ballooning was performed.Ballooning was performed in the proximal landing area and slightly out of the proximal area.After about 5 minutes, a sudden drop in blood pressure was observed.Emergency contrast was performed from the ascending aorta, and extravascular contrast was observed, suggesting a rupture of the ascending aorta.The patient went into cardiac arrest and was diagnosed with cardiac tamponade.When open chest surgery was performed with cardiac massage, there was a crack in the blood vessel (aortic arch) between the bare stent and the sealing stent of the stent graft on the lesser curvature side, and the bleeding point was closed by the procedure, but the heartbeat did not return.The chest was closed with pcps (percutaneous cardiopulmonary support) turned on, and the patient was returned to the room.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: a patient (79 year old male) underwent thoracic endovascular aortic repair (tevar) to treat an excessive aortic aneurysm.Because of the need to place a stent graft from zone 2 and due to shaggy aorta anatomically, bypass was avoided by performing a left subclavian artery (lsa) fenestration of site's own making.After zta-p-32-201-w1 was deployed at distal, zta-p-34-209-w1 (complaint device) was piled up and deployed, and contrast was performed.The landing zone had a planned length of 29mm and a diameter of 31mm.Due to calcification in the proximal landing zone a potential endoleak was anticipated and after deployment a type 1a endoleak was confirmed.The endoleak was treated with balloon angioplasty within and slightly proximal to the landing zone.Five minutes afterwards, a sudden drop in blood pressure was observed.Emergency contrast was performed from the ascending aorta and extravascular contrast was observed suggesting a rupture of the ascending aorta.The patient went into cardiac arrest and was diagnosed with cardiac tamponade.When open chest surgery was performed with cardiac massage, there was a crack in the blood vessel (aortic arch) between the bare stent and the sealing stent of the stent graft on the lesser curvature side.The bleeding point was closed by the procedure, but the heartbeat was never recovered, and the patient deceased.The chest was closed with pcps (percutaneous cardiopulmonary support) turned on, and the patient was returned to the room.The physician has commented that the ballooning in the proximal area was superfluous and upon inspecting the aortic rupture it seems to have torn from the calcification area.An imaging review of the provided planning/sizing 3d reconstructions was performed by an imaging expert.The following is the imaging reviewers¿ findings ¿a large, calcified plaque was present on the inner aortic curvature at the expected location of the bare sealing stent junction and the reported rupture.With a zone ii implantation, a 29mm seal zone length was achievable.Because the aneurysm neck extended into the left lsa origin, a zone iii implant was not feasible.The reported lsa fenestration would have been located between the sealing stent and second mainbody stent if the sealing stent was implanted exactly at the left cca (common carotid artery) trailing edge.¿ based on these findings the imaging reviewers¿ impressions are ¿the complaint report¿s characterization of the proximal seal zone lumen as ¿shaggy¿ is not confirmed.The provided images demonstrate a mild to moderately calcified (25-50% circumference) seal zone that should have spontaneously sealed given time.The reported off label lsa fenestration may have potentiated the type ia endoleak by significantly shortening the effective seal zone length.¿ the imaging review could not confirm the event as imaging of the endoleak precipitating angioplasty, molding balloon angioplasty, and/or the rupture was not provided.Review of the device history record gave no indication of the device being produced out of specification.Upon review of the provided information, it is not possible to determine an exact cause of the type 1a endoleak, but it cannot be ruled out that the off-label left subclavian artery fenestration of the stent-graft may have significantly shortened the effective seal zone length as the fenestration was performed near the proximal end of the stent-graft.It should be noted that the modification made to the stent graft is not supported by instructions for use or clinical testing of the device and is out of cook's control and considered off-label use.The reported rupture is assessed to be related to ballooning of the proximal landing zone in an effort to seal the type 1a endoleak.The physician has commented that the ballooning of the proximal seal zone was superfluous.The impression from the imaging review was that although calcification was present the seal zone should have spontaneously sealed given time.Cook medical will continue to monitor for similar events.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

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 4632 ; DA 4632
• Manufacturer Contact: henriette s. christiansen ; sandet 6, dk-4632; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 17894700
• MDR Text Key: 325227810
• Report Number: 3002808486-2023-00254
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449555
• UDI-Public: (01)10827002449555(17)260427(10)E4399562
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

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 Catalogue Number: ZTA-P-34-209-W1
• Device Lot Number: E4399562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2023
• 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
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Sex: Male