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

Catalog Number	ZTA-PT-38-34-167-W
Medical Device Problem Codes	Off-Label Use (1494); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter.A patient of undisclosed gender and age underwent a tevar (thoracic endovascular aortic repair) procedure in which the zenith alpha thoracic endovascular graft proximal tapered components, was used.When the graft was unsheathed in the patient the third stent from the top would not open fully.It was constrained about fifty percent.The surgeon used a coda balloon to open the stent successfully.It was a dissection, patient had some tears in their aorta patient outcome: district manager contacted the surgeon one day post-op and surgeon confirmed the patient was doing well.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).G4) pma/510(k) p140016 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 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
Manufacturers (b)(4).Summary of investigational findings: a patient of undisclosed gender and age with dissection, underwent a tevar (thoracic endovascular aortic repair).In which, zta-pt-38-34-167-w (complaint device) was used.When the graft was unsheathed in the patient, the third stent from the top would not open fully.It was constrained about fifty percent.The surgeon used a coda balloon to open the stent successfully.No additional interventions were performed, due to this occurrence.Per, the reported information, the black safety-lock knob was turned in the direction of the arrows until a slight click was felt and the blue rotation handle turned in the direction of the arrow until a stop was felt, as per ifu (instructions for use).No difficulties were experienced, during rotation of the rotation handle.The stent graft implanted in the planned target zone.There was not any part of the procedure off label or out of patient selection criteria.District manager contacted, the surgeon one day post-op and surgeon confirmed, the patient was doing well.Review of the device history record gave no indication, of the device being produced out of specification.No imaging was provided.And no device was returned.Based on the provided information, it has not been possible to establish the cause of the incomplete expansion of the stent graft.It is noted, that zta device is used for treatment of dissection.Per the ifu (instructions for use): the zta, is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta.And the safety and effectiveness of the zta have not been evaluated in the patients with dissections.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.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED 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; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: alex rahbek ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 18605230
• Report Number: 3002808486-2024-00017
• Device Sequence Number: 9154281
• Product Code: MIH
• UDI-Device Identifier: 10827002381800
• UDI-Public: (01)10827002381800(17)261012(10)E4460006
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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 Catalogue Number: ZTA-PT-38-34-167-W
• Device Lot Number: E4460006
• 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: 01/12/2024
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2023
• 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