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

Model Number G35359

Device Problems Off-Label Use (1494); Loosening of Implant Not Related to Bone-Ingrowth (4002); Material Too Soft/Flexible (4007)

Patient Problems No Information (3190); Insufficient Information (4580)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: per the findings in the imaging review: the three superior apices of the zta-p-38-167-w distal stent segment were inverted distally into the lumen.Two markers were also bunched from stent wires sliding through their sutures.Patient submitted to the hospital tuesday (b)(6) 2020, with chest pain following a tevar on (b)(6) 2020.Ct revealed possible type 1a endoleak at the lsa (prox edge of initial graft zta-pt-38-34-217-w) ((b)(6)).The doctor called me (b)(6) 2020 with a plan to extend proximally with a short 36 or 38mm alpha.He indicated that he begin with lsa/lcc bypass along with a vbx ¿snorkel¿ through the lcc via the left arm so he could extend the proximal edge of the graft over the lcc to the innominate.This plan was put into effect and he positioned a zta-p-38-167-w over a 300 couble curved lunderquist and initiated deployment of the graft after aortogram and marking of landmarks.The initial deployment went according to plan with the positioned right at the distal edge of the innominate artery.However, in the next instant the graft was fully deployed and 3cm past the innominate into the ascending aorta.The aortic lumen in this area was approximately 40mm and anesthesia confirmed on multiple occasions that there were no concerning changes in blood pressure or otherwise with patient throughout the rest of the case.The doctor unsuccessfully attempted pull the device back, so he completed steps in releasing the device and called another doctor to discuss options.The decision was made to cut down on the right axillary artery and place an additional vbx ¿snorkel¿ via the innominate next to the lcc snorkel.This was successfully accomplished.A 14x20mm atlas was used to post dilate the portion of the vbx within the 13.5mm innominate lumen.The doctor also used a tri-lobe balloon just distal to the lcc to minimize risk of continued type 1a endoleak.Final angiogram showed good flow to innominate & lcc but was inconclusive with regards to endoleak.Decision was made to close and take ct scan at later date.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: this complaint was opened based on a finding in the imaging review for (b)(4), where it is found that the three superior apices of the zta-p-38-167-w (complaint device) distal stent segment were inverted distally into the lumen.Two markers were also bunched from stent wires sliding through their sutures.The complaint concerns a female 69 year old patient with a symptomatic type a imh with a feeding ulcer 3 cm from the subclavian artery (sca) who went through a tevar on (b)(6)2020.A zta-pt-38-34-217-w was placed, landing at left subclavian artery (lsa).On (b)(6) 2020 the patient submitted to the hospital with chest pain.Ct revealed possible type 1a endoleak at the lsa (left subclavian artery) ((b)(4)).Per the information received the physician planned to extend proximally, over the lcc (left common carotid artery) to the innominate artery.After performing an lsa/lcc bypass along with a vbx ¿snorkel¿ through the lcc, the physician advanced a zta-p-38-167-w over a 300 double curved lunderquist wire and initiated deployment of the graft after aortogram and marking of landmarks.The initial deployment went according to plan with the positioned right at the distal edge of the innominate artery.However, in the next instant the graft was fully deployed and 3cm past the innominate into the ascending aorta ((b)(4)).The physician unsuccessfully attempted pull the device back, so he completed the deployment.The physician then cut down on the right axillary artery and place an additional vbx ¿snorkel¿ via the innominate artery next to the lcc snorkel.Ballooning was performed to minimize risk of continued type 1a endoleak.Final angiogram showed good flow to the innominate artery and lcc but was inconclusive with regards to endoleak.The physician decided to close and take ct scan at later date.No adverse events related to the inverted stent segment was reported.It was reported that the patient will be seen for a follow up ct.Review of the device history record gave no indication of the device being produced outside of specifications.Preoperative (prior to the initial tevar) and post implantation ctas (post second tevar) were reviewed along with the complaint report by an imaging expert.Per the imaging reviewers¿ findings, the three superior apices of the zta-p-38-167-w distal stent segment were inverted distally into the lumen.Two markers were also bunched from stent wires sliding through their sutures.The adjacent superior stent wire apex also slid through its sutures.Per the imaging reviewer¿s impression, the distal zta-p-38-167-w stent segment wire was partially inverted.The wire of the adjacent stent segment slid along its sutures.These findings are related to the same event which had to act on both sides of the distal endograft simultaneously.This could have occurred through attempted retraction with another device or possibly through unsheathing.Alternative but less likely, the deformity could have been caused by unreported repositioning attempts.Based on the provided information it is not possible to establish an exact cause for this event.It is noted that it was planned to place the zta-p-38-167-w with covering the lcca with a snorkeling stent in the seal zone.Per the ifu ¿the zenith alpha thoracic endovascular graft is designed to treat proximal aortic necks (distal to either the left subclavian or left common carotid artery) of at least 20 mm in length¿.And also the ifu instructs to ¿land the proximal and the distal ends of the device in parallel aortic neck segments without acute angulation (> 45 degrees) or circumferential thrombus/calcification to ensure fixation and seal.¿ it is also noted that the physician made an attempt to pull the device back after unsheathing the implant.The ifu states that during sheath withdrawal, the proximal barbs are exposed and are in contact with the vessel wall.At this stage it may be possible to advance the device, but retraction may cause aortic wall damage.Cook will reopen the case if further information or images becomes available.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: 11356929
• MDR Text Key: 242432994
• Report Number: 3002808486-2021-00136
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002353593
• UDI-Public: (01)10827002353593(17)230312(10)E3961672
• Combination Product (y/n): N
• PMA/PMN Number: P140016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

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: 03/12/2023
• Device Model Number: G35359
• Device Catalogue Number: ZTA-P-38-167-W
• Device Lot Number: E3961672
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 09/23/2021
• Supplement Dates FDA Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 69 YR