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

Model Number G35337

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Packaging Problem (3007)

Patient Problem Unspecified Infection (1930)

Event Type  Death  

Manufacturer Narrative

Manufacturer ref# (b)(4).Date of death: (b)(6) 2021.Pma/510(k): p140016.Investigation is still in progress.

Event Description

Description of event according to initial reporter: email 28apr2022: the physician deployed the device in the thoracic aorta just distal to the left subclavian artery.The device deployed normally and had no technical issues.The graft landed slightly distal to where they wanted to land but were happy with the result after angiogram.Patient came back to hospital a week after release and passed away from infection.Aorta and graft were infected.She is unsure as to why this happened and what caused infection.Patient outcome: patient passed away.

Event Description

Additional information received 28apr2022.Date of implant: on (b)(6) 2021.Date of death: on (b)(6) 2021.

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 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).After investigation the event for this pr# is no longer reportable as nothing indicates that the event is related to fault conditions of the device or the use of the device for a patient with traumatic dissection.The patient would have an increased risk of infection due to a multi system trauma.H6: c22 - appropriate term/code not available for side effect.D17 - appropriate term/code not available for side effect.Summary of investigational findings: a male patient of an unknown age with a multi system trauma underwent a tevar (thoracic endovascular aortic repair) on (b)(6) 2021 due to a traumatic dissection, where a zta-p-28-109-w (complaint device) was implanted just distally to the lsa (left subclavian artery).Per the reported info, the stent graft landed slightly distally to the target site, but the physician was satisfied with the result after angiogram.Patient came back to the hospital a week after the procedure and passed away from infection.Aorta and graft were infected but no positive blood cultures.The physician is unsure why this happened and what caused infection.Per the reported information, there was no damage, or any issues noticed during inspecting the box or packaging.No imaging and autopsy report is available.Medical advisor clinical assessment was performed.Per clinical assessment "based on the provided information it has not been possible to establish an exact cause.Although there seems to be a relatively close timeline (within the same month) between the implantation and the infection it is not assessed appropriate to conclude on any causality between device and infection due to very limited information.There is no detailed information about the infection/microorganisms involved, or potentially other surgeries/invasive procedures performed due to other traumas.Also, unintentionally contamination during surgical intervention is a known risk factor.No indication on damaged to package prior to use or fault device.As stated in the information the procedure was performed treating a traumatic dissection which is outside ifu.But this is not assessed to have any causal effect on the event".Review of the device history record gave no indication of the device being produced out of specification.Nothing indicates that the event is related to fault conditions of the device or the use of the device for a patient with traumatic dissection why the infection is assessed to be related to the procedure.The patient would have an increased risk of infection due to a multi system trauma.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
• 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: 14336931
• MDR Text Key: 291211948
• Report Number: 3002808486-2022-00300
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002353371
• UDI-Public: (01)10827002353371(17)240319(10)E4087410
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2024
• Device Model Number: G35337
• Device Catalogue Number: ZTA-P-28-109-W
• Device Lot Number: E4087410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• 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 Sex: Male