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-46-233-W1

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Description of event according to initial reporter: a (b)(6) male patient underwent tevar using zta-p-46-233-w1.The target aneurysm was located in the area between the aortic arch and the descending aorta.Since the stentgraft was planned to be placed in the zone 1, 2, debranch was performed prior to tevar.The maximum diameter of the proximal neck was 43mm.The complaint zta-p-46-233-w1 was advanced to the target site by right femoral approach.After the physician adjusted the location of the proximal end of the stentgraft to the location under the brachiocephalic artery, while controlling the blood pressure with rapid-pacing, deployment of the stentgraft was begun.However, due to the pro-form tie, bare alignment stent/the proximal part of the stentgraft expanded bent at approximately 90 degrees against lesser curvature.Trigger wire and pro-form tie were released by manipulating the handle then, but the stentgraft did not follow the lesser curvature and its proximal end was still bent severely((b)(4)).Touch-up ballooning was performed with coda-2-10.0-35-120-40, which fixed bend of the stentgraft, but the most proximal stent was pushed into the second most proximal stent to a small extent.Consequently, length of the landing of the stentgraft on the lesser curvature became shorter than that of planned.A second stentgraft was placed then, followed by an distal extension, which was placed in the overlapped part of the previously placed two stentgrafts.Final angiography confirmed a slight proximal type 1 endoleak.The leak flowed into the aneurysm through the sealed area between the stentgraft and the lesser curvature.So, touch-up ballooning was performed again.Although slight appearance of endoleak remained there ((b)(4)), the physician judged it as a minor leak and completed the procedure.Patient outcome: no adverse effects to the patient.

Manufacturer Narrative

Exemption number e2016032.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.: 3005580113.H6) ec method code: 4109 - historical data analysis.4112 - analysis of data provided by user/third party.4117 - device not accessible for testing.Ec evaluation code: 4315 ¿ cause not established.Summary of investigational findings: in this complaint file it is stated that the bare alignment stent and proximal part of the stent graft was deployed bent approximately 90 degrees against the lesser aortic curvature.Coda ballooning was performed which fixed the bending of the stent graft, but the most proximal stent was pushed into the second-most proximal stent to a small extent.The length of the seal zone on the lesser curvature became shorter than planned.A second stent graft was inserted distally, followed by a distal extension which was placed in the overlap between the two previous stentgrafts.Angiography confirmed a slight type 1a endoleak at the lesser curvature.Ballooning was performed again to correct the endoleak, but a minor leak remained at the completion of the procedure.No adverse effects to the patient have been reported.According to the reported information, debranching was performed prior to tevar.The device was deployed in zone 1 while rapid pacing was performed.The maximum diameter of the proximal neck was 43mm.The imaging review is based on the provided pre-implantation imaging.According to the imaging review, the elongated arch was type iii.Although not strictly the ascending aorta, the choice of an lshimaru zone 1 seal in a type ill arch provides the same anatomic challenges as the ascending aorta.The intended seal zone in lshimaru zone 1 measured 41.5mm in diameter at the innominate artery trailing edge and 43mm another 20mm distal along the aortic centerline.More distally, the aorta rapidly flared into the aneurysm sac.The aortic curvature radius of 21.5mm was just above the ifu cutoff.The imaging review also noted that because the seal zone diameter was outside the ifu on its distal margin and because the aorta then rapidly flared into the aneurysm, implantation of the sealing stent short of the innominate artery trailing edge would likely have shortened the achieved seal zone less than the ifu recommended 20mm and would have increased the risk of type ia endoleak.Based on the provided information and imaging it has not been possible to determine the cause of the angulated deployment of the bare stent and proximal part of the stent graft.Whether the proximal sealing zone maximum diameter of 43mm (outside intended use) or whether deployment in zone 1 has contributed to the angulated deployment and reported endoleak has not been possible to determine.The reported information states that the length of seal zone on the lesser curvature became shorter than intended, after the angulated deployed proximal part of the stent graft had been corrected with ballooning.Following this a type ia endoleak was observed through the sealed area between the stentgraft and the lesser curvature.This indicates that the type 1a endoleak was likely secondary to the angulated deployment of the stent graft and balloon correction and therefore cascade.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.

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: 7624176
• MDR Text Key: 111834816
• Report Number: 3002808486-2018-00712
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449791
• UDI-Public: (01)10827002449791(17)210109(10)E3669111
• 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: 10/04/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2021
• Device Catalogue Number: ZTA-P-46-233-W1
• Device Lot Number: E3669111
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/31/2018
• Device Age: 5 MO
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: 09/14/2018
• Supplement Dates FDA Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 79 YR