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-42-38-173-W1

Device Problems Bent (1059); Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 04/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Name and address for importer site: (b)(4).Similar to device under 510(k) p140016.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: on (b)(6) 2018, a (b)(6) male patient had undergone total aortic arch replacement 17 years ago due to type a dissection.The remaining native aorta below the distal side of the aortic arch was turned into an aneurysm.Tevar this time was to close an entry and cover the dissecting aneurysm of the aorta.The patient was not suitable for the procedure because the patient had aortic dissection as a pre-existing condition and the procedure was to treat the dissecting aneurysm of the aorta.However, the physician chose tevar with zenith alpha because the access route was not difficult for zenith although it would be difficult for other manufacturers' devices since delivery system of zenith alpha was 1mm~1.5mm thinner than competitor¿s ones.(proximal neck length at the lesser curvature of the vessel wall side was 22mm.There was no problem in a vessel shape and landing zone for the procedure.) plan of the procedure: place an extension device (zta-de-26-104-w1) in the distal site first due to a gap between proximal and distal diameters, then zta-pt-34-30-161-w1 in the middle, then zta-pt-42-38-173-w1 (complaint device) in the proximal site (from zone 3).The procedure was being conducted by right fa approach with no problem until completing the second stent graft placement (zta-pt-34-30-161-w1).After that, the delivery system of zta-pt-42-38-173-w1 was advanced to zone 3, then location of vessel branches was confirmed with angiography.The stent graft was successfully deployed, but once a trigger wire was released, the sealing stent was placed bent and got into the second stent, which made the proximal side of the stent graft unsealed to the lesser curvature of the vessel wall and caused type ia endoleak.(the second stent was located on the anastomosis site of the blood vessel prosthesis.) balloon devices (gore/ bcl2645j and cook¿s coda-2-10.0-35-120-40 (lot: 7843474)) were used in an attempt to fix the bent, but the ballooning could not solve it.The procedure was finished with no additional treatment on the day with remaining type ia endoleak.Additional treatment with another manufacturer¿s device is scheduled to be conducted at a later date.Patient outcome: hospitalization prolonged.The patient has not recovered as of (b)(6) 2018.

Event Description

Description of event according to initial reporter: on (b)(6) 2018, a 70-year-old male patient had undergone total aortic arch replacement 17 years ago due to type a dissection.The remaining native aorta below the distal side of the aortic arch was turned into an aneurysm.Tevar this time was to close an entry and cover the dissecting aneurysm of the aorta.The patient was not suitable for the procedure because the patient had aortic dissection as a pre-existing condition and the procedure was to treat the dissecting aneurysm of the aorta.However, the physician chose tevar with zenith alpha because the access route was not difficult for zenith although it would be difficult for other manufacturers' devices since delivery system of zenith alpha was 1mm~1.5mm thinner than competitor¿s ones.(proximal neck length at the lesser curvature of the vessel wall side was 22mm.There was no problem in a vessel shape and landing zone for the procedure.) plan of the procedure: place an extension device (zta-de-26-104-w1) in the distal site first due to a gap between proximal and distal diameters, then zta-pt-34-30-161-w1 in the middle, then zta-pt-42-38-173-w1 (complaint device) in the proximal site (from zone 3).The procedure was being conducted by right fa approach with no problem until completing the second stent graft placement (zta-pt-34-30-161-w1).After that, the delivery system of zta-pt-42-38-173-w1 was advanced to zone 3, then location of vessel branches was confirmed with angiography.The stent graft was successfully deployed, but once a trigger wire was released, the sealing stent was placed bent and got into the second stent, which made the proximal side of the stent graft unsealed to the lesser curvature of the vessel wall and caused type ia endoleak.(the second stent was located on the anastomosis site of the blood vessel prosthesis.) balloon devices (gore/ bcl2645j and cook¿s coda-2-10.0-35-120-40 (lot: 7843474)) were used in an attempt to fix the bent, but the ballooning could not solve it.The procedure was finished with no additional treatment on the day with remaining type ia endoleak.Additional treatment with another manufacturer¿s device is scheduled to be conducted at a later date.Patient outcome: hospitalization prolonged.The patient has not recovered as of (b)(6) 2018.

Manufacturer Narrative

Exemption number (b)(4).William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404.Registration no.: (b)(4).H6) ec method code: 4112 - imaging.Summary of investigational findings: as per the reported information the patient, who at a previous time point had aortic arch replacement, underwent treatment for a dissecting aneurysm in the native part of the aorta on the distal side of the aorta arch.In the current procedure, a zta-de device and zta-pt device were inserted prior to the complaint device.The complaint device was inserted from zone 3 as the most proximal of the components.The proximal sealing stent was deployed bent and got into the second stent, which made the proximal side of the stent graft unsealed towards the inner curvature of the vessel wall.Following, a type ia endoleak was observed, which remained after the procedure and was scheduled to be treated at a later date.According to the imaging review, upon deployment of the uncovered stent, the proximal aspect of the sealing stent appears to expand before the distal aspect of the sealing stent, causing the proximal edge to slightly ¿fall back¿ along the lesser curve.The sealing stent fully expands and the device appears to be appropriately conformed to the aorta.The proximal sealing stent appears to have deployed slightly further back along the lesser curve compared to where it is initially positioned before release of the uncovered stent.According to the review, it cannot be determined if this is due to the deployment mechanism, the operator¿s technique, or the patient¿s aortic arch anatomy.Furthermore, the suitability of the proximal landing zone cannot be determined from the imaging provided and the patient is reported to have had aortic arch replacement in the past and this could impact the anatomy and deployment of the thoracic device.The review confirmed observation of a type 1a endoleak on the completion angiogram.Based on the provided imaging and information, it has not been possible to determine the cause for this event.No evidence to suggest that the product was not manufactured according to specifications.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 TAPERED COMPONENTS
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 7439089
• MDR Text Key: 105754475
• Report Number: 3002808486-2018-00476
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002448701
• UDI-Public: (01)10827002448701(17)201221(10)E3667933
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2020
• Device Catalogue Number: ZTA-PT-42-38-173-W1
• Device Lot Number: E3667933
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/04/2018
• Device Age: 4 MO
• Date Manufacturer Received: 07/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention