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-34-161-W1

Device Problems Material Frayed (1262); Failure to Advance (2524)

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

Event Date 07/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is similar to device under 510(k) p140016.Investigation is still in progress.

Event Description

Description of event according to initial reporter: a (b)(6) female patient underwent taa repair.The access vessel was partially narrowed and the aorta was partially tortuous, but the physician determined that delivery systems would be advanced.The treatment area was long.Zta-p-34-209-w1 was placed from right below the left subclavian artery, and then zta-d-34-190-w1 was placed with approx 3 stens and proximal bare stent overlapping.The overlap was slightly short because the physician gave priority to the distal landing point.After ballooning was performed, endoleak that was seemed to be type iv and/or type iii was confirmed, so additional ballooning was performed.However, the endoleak was not solved, so the physician decided to place zta-p-34-161-w1 to cover the junction and as many part of zta-p-34-209-w1.((b)(4)) he inserted the delivery system of zta-p-34-209-w1 from the right femoral but could not advance to the target site.It could be due to interference of previously placed stent grafts.He tried to advance it from the left femoral but failed.He felt strong resistance as if it got caught with something, so he removed it from the patient and found the device tip was frayed.He gave up on using this device to avoid the risk of vessel damage.((b)(4)).Zta-de-34-112-w1 was used instead and the stent graft was placed successfully to cover the junction and as many part of zta-p-34-209-w1.He confirmed that the endoleak was solved and completed the procedure.Patient outcome: the patient did not experience any adverse events due to this occurrence and is doing fine after the procedure.

Event Description

Updated device rpn in description of event: a 72 year old female patient underwent taa repair.The access vessel was partially narrowed and the aorta was partially tortuous, but the physician determined that delivery systems would be advanced.The treatment area was long.Zta-p-34-209-w1 was placed from right below the left subclavian artery, and then zta-d-34-190-w1 was placed with approx 3 stens and proximal bare stent overlapping.The overlap was slightly short because the physician gave priority to the distal landing point.After ballooning was performed, endoleak that was seemed to be type iv and/or type iii was confirmed, so additional ballooning was performed.However, the endoleak was not solved, so the physician decided to place zta-p-34-161-w1 to cover the junction and as many part of zta-p-34-209-w1.(b)(4).He inserted the delivery system of zta-p-34-161-w1 from the right femoral but could not advance to the target site.It could be due to interference of previously placed stent grafts.He tried to advance it from the left femoral but failed.He felt strong resistance as if it got caught with something, so he removed it from the patient and found the device tip was frayed.He gave up on using this device to avoid the risk of vessel damage.(b)(4).Zta-de-34-112-w1 was used instead and the stent graft was placed successfully to cover the junction and as many part of zta-p-34-209-w1.He confirmed that the endoleak was solved and completed the procedure.

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.H11) corrected data: b5) description of event.Device rpn have been updated.Investigation is still in progress.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 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: 7760929
• MDR Text Key: 116397844
• Report Number: 3002808486-2018-00883
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449548
• UDI-Public: (01)10827002449548(17)210123(10)E3678741
• 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: 11/15/2018

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: 01/23/2021
• Device Catalogue Number: ZTA-P-34-161-W1
• Device Lot Number: E3678461
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/17/2018
• Device Age: 6 MO
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 10/24/2018
• Supplement Dates FDA Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 47