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-42-225-W1

Device Problem Failure to Advance (2524)

Patient Problem Tissue Damage (2104)

Event Date 04/12/2018

Event Type  malfunction  

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: a male patient underwent taa repair.The average size of the access vessel was 7.5mm.The aorta was strongly tortuous at the level of the diaphragm.The taa was the large saccular aneurysm located at the greater curvature of the aorta arch.After performing 2 debranch, zta-p-40-217-w1 was inserted from the right femoral artery and the stent graft was placed.(update added 16apr2018): the stent graft's proximal side was placed at the origin of the aneurysm and the distal side was placed at the proximal of the strongly tortuous part at the level of the diaphragm.Then the physician inserted zta-p-42-225-w1 to deploy the stent graft proximally to the first one.However, the tip of the delivery system got caught in the proximal side of the first one and became unable to advance any further.There was no way to advance it to the target site, so he replaced it with gore's c-tag.(pr#(b)(4)) he inserted gore's 24fr dryseal flex sheath and inserted the c-tag into it and the c-tag could be advanced and the stent graft was placed successfully, but the damage of the vessel was confirmed by angiography after the delivery system of the c-tag was removed.He placed gore's excluder legs to repair the vessel damage.Arrest of bleeding was confirmed and the procedure was completed.(pr#(b)(4)) additional information provided on 19apr2018: the damage area of the vessel was the right common iliac artery to the right external iliac artery and the physician thinks the cause of the damage was insertion of gore's 24fr dryseal flex sheath into the small vessel in order to insert the c-tag.Patient outcome: no adverse effects on the patient due to this occurrence was reported as of today.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi), 400 daniels way, bloomington, in 47404, registration no.: 3005580113.Summary of investigational findings: it is reported in this complaint that during advancement of the complaint device (zta-p-42-225-w1, cook), the tip of the delivery system got caught in the proximal side of the before implanted zta-p-40-217-w1 (cook) stent graft.The previous implanted zta had been placed with the distal side at the proximal of the strongly tortuous part of the aorta at the level of the diaphragm.The delivery system of the complaint device could not be advanced further.Instead, a gore 24fr sheath was inserted, through which a gore c-tag was implanted.After the delivery system of the c-tag was removed, damage to the right iliac arteries was observed.The vessel damage was corrected with placement of additional devices and the procedure was completed.A separate complaint was opened to address the reported vessel damage indicated to be related to the right iliacs.The current complaint was opened based on the investigation of the first complaint.The current complaint addresses the advancement difficulties which were indicated to be related to anatomy proximal to the diaphragm, which is separate to the event in the first complaint.According to the information reported in the complaint file, the aneurysm was located at the greater curvature of the aorta arch and the aorta was strongly tortuous at the level of the diaphragm.After performing 2 debranch, a zta-p-40-217-w1 was implanted prior to the complaint device.The stent graft's proximal side was placed at the origin of the aneurysm and the distal side was placed at the proximal side of the strongly tortuous part at the level of the diaphragm.Then the physician inserted the complaint device, to deploy the stent graft proximally to the first one.The tip of the delivery system got caught in the proximal side of the previously implanted device and could not be advanced further.According to the information in the complaint file, the customer has noted that the failure of advancing the delivery system may have been due to failure of torque transmission due to the strongly tortuous aorta.Pre-implantation cta with 3d reconstructions was provided for the imaging review.The imaging reviewing physician noted in the imaging review that: "the aorta was severely tortuous.The arch was type ill with at least a 6cm diameter aneurysm originating at the left subclavian artery (lsa) origin.Although the aneurysm was fusiform, it primarily projected superiorly such that the apex of the arch was the apex of the mid aneurysm."."the descending thoracic aorta was severely elongated with variable wall thickening from mixed atherosclerotic and aneurysmal disease.In the mid descending thoracic aorta, a smaller aneurysm was located just superior to a 90 degree bend.Aortic wall thickness and dilation continued to a second 90 degree bend just proximal to the diaphragmatic crus."."reportedly two aortic arch branches, the left common carotid artery (lcca) and lsa were occluded and presumably bypassed.This placed the intended proximal seal zone in lshmaru zone 1 and 2, spanning from the innominate artery trailing edge across the lcca ostium to the lsa trailing edge".Furthermore: "according to the aortic centerline, the zta-p-40-217-w1 would have spanned from the aneurysm neck to the proximal margin to the 90 degree aortic bend just superior to the diaphragmatic crus.This matches the complaint report description.Since this endograft was implanted first, its distal stent would have been perpendicularly aligned with the zta-p-42-225-w1 delivery system tip and tip sheath transition.Once the zta-p-42-225 -w1 was caught on the zta-p-40- 217-w1 distal stent, it would continue to catch unless by rotation the zta-p-42- 225-w1 could be directed away from the catch point.Inability to rotate the delivery sheath correlates with the "failure of torque transmission" described in the complaint report".It was concluded in the imaging review: ".The pre-procedure imaging confirms the potential to entrap the zta- p-42-225-w1 in the distal zta-p-40-217 -w1.The complaint report's placement of the zta-p-40-217-w1 distal end just proximal a severe distal thoracic aortic bend in a position to prevent advancement of the zta-p-42-225-w1 is confirmed by the pre-procedure imaging.Severe aortic tortuosity that would have impeded zta-p advancement and rotation is confirmed." the ifu recommends that no localized angulation should be larger than 45 degrees.As imaging from the procedure has not been available for the investigation it has not been possible to determine the exact cause for the reported advancement difficulties.However, a likely cause for the difficulties in advancing the device is related to severe aortic tortuosity.No evidence to suggest that this device 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.

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
• MDR Report Key: 7756120
• MDR Text Key: 116871129
• Report Number: 3002808486-2018-00897
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449715
• UDI-Public: (01)10827002449715(17)201221(10)E3667919
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/07/2018

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 Expiration Date: 12/21/2020
• Device Catalogue Number: ZTA-P-42-225-W1
• Device Lot Number: E3667919
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/11/2018
• Device Age: 4 MO
• Initial Date Manufacturer Received: 07/11/2018
• Initial Date FDA Received: 08/07/2018
• Supplement Dates Manufacturer Received: 01/18/2019
• Supplement Dates FDA Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1