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-28-201-W1

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.G4) similar to device under pma/510(k) p140016 summary of investigational findings: a 64 year old male patient with dissection underwent scheduled tevar (thoracic endovascular aortic repair) on (b)(6) 2023 where zta-p-28-201-w1 (complaint device) was attempted to be delivered to the target site approaching from right femoral artery with a guidewire (terumo/radifocus, stiff type shaped j) using pull-through technique.However, there was an s shape curvature (tortuosity) at the diaphragm level and the delivery system could not be advanced.The physician put tension on the pull-through by going up and down many times, but the device did not advance.Therefore, he attempted to pull out the delivery system from the guide wire once and try again.But the delivery system could not be pulled out, so he removed both the delivery system and the guide wire.After he pulled them out, he attempted to pull out the guide wire, but it could not be pulled out of the delivery system, so he changed to the same device (unknown lot#), and he completed the procedure without any problems.The physician thought the bend was so strong that the guide wire may have bent, or the wire lumen of the delivery system may have bent.Cook research incorporated (cri) has performed imaging review of provided planning/sizing 3d reconstruction and procedural image.Review of 3d reconstruction and planning/sizing schema found that it shows severe s-shaped tortuosity of descending thoracic aorta.The annotated angle measurements (on the 3d reconstruction) of 81-degrees at the mid ta and 58-degrees at the distal ta was remeasured by cri to be 139-degrees and 131-degrees, respectively.Review of the single procedural static image found that it shows a severe bend of the zta device at the proximal dilator component and another severe bend at the distal graft segment in the distal ta.The conclusion from the image review is that there was likely kinking of the guidewire within the delivery system or kinking of the wire lumen of the delivery system itself due to the severe s-shaped tortuosity of the descending ta.The image review also conclude that the angulations of at the mid and distal ta segments is well outside the ifu for the zta device.The complaint device zta-p-28-201-w1 was returned for evaluation without shipping stylet, without peel away and with wire guide inside the device.Scrape off and/or missing coating were located in three areas of the terumo wire guide.Based on the findings in the device evaluation, it is likely that that the terumo wire guide was stuck on the device due to coating-scrape off inside the cannula tube, which possibly blocked the passage.The scrape off might have been caused by tension during advancement of the device over the terumo wire guide through a very tortuous anatomy reported as s-shape curvature at the diaphragm level.A compression was observed on the sheath which also might have occurred during the advancement of the device through a very tortuous anatomy.Review of the device history record gave no indication of the device being produced out of specification.Based on provided information, imaging review and device evaluation the most likely cause for the inability to advance the device over the wire guide to the target location was the severe tortuosity of the patient anatomy which when re-measured as part of the imaging review was concluded to be 139- and 131-degrees, respectively which is outside the ifu.According to the ifu, no localized angulation should be larger than 45 degrees.Evaluation of the returned device found that it is likely that that the terumo wire guide was stuck in the device due to coating-scrape off inside the cannula tube and that the scrape off might have been caused by the tension during advancement of the device through the tortuous anatomy.It is noted that zta device was used for treatment of dissection, which is outside intended use for this type of the device.According to the ifu, 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 devices have not been evaluated in the patients with dissections.Initially this event was considered not reportable however after investigation if has become clear that the device cannot be ruled out as a contributing factor, similar event have been reported that has led to serious injury.Therefore, the event is considered reportable from 08feb2024.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

Description of event according to initial reporter: patient underwent scheduled general tevar on (b)(6) 2023.Zta-p-28-201-w1 was attempted to be delivered to the target site approaching from right femoral artery with a guidewire (terumo/radifocus, stiff type shaped j) using pull-through technique.However, there was an s shape curvature at the diaphragm level and the delivery system could not be advanced.The physician put tension on the pull-through by going up and down many times, but the device did not advance.Therefore, he attempted to pull out the delivery system from the guide wire once and try again.But the delivery system could not be pulled out, so he removed both the delivery system and the guide wire.After pulled them out, he attempted to pull out the guide wire, but the it could not be pulled out of the delivery system, so he changed to the same device (unknown lot#), and he completed the procedure without any problems.The physician thought the bend was so strong that the guide wire may have bent, or the wire lumen of the delivery system may have bent.Patient outcome: no health hazard.

• 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; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: alex rahbek ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 18738295
• MDR Text Key: 336749511
• Report Number: 3002808486-2024-00032
• Device Sequence Number: 1
• Product Code: MIH
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZTA-P-28-201-W1
• Device Lot Number: E4137737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2021
• 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 Age: 64 YR
• Patient Sex: Female