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-42-173-W1

Device Problem Bent (1059)

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

Event Date 04/02/2018

Event Type  Injury  

Manufacturer Narrative

(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: (b)(6) year old male patient who has shaggy aorta underwent taa repair.Both right / left access route were within ifu, so right fa was chosen as main access route.First, zta-p-42-173-w1 was placed from zone 4 with normal procedure.At deployment, the stent was placed with the lesser curvature side of the proximal sealing stent bent due to function of 'pro -form tie'.So the physician performed angiography and it was confirmed that the proximal type i endoleak from the lesser curvature.He managed to fix the bent using a balloon catheter (coda, cook medical) by touch-up.The floating area of the stent was fixed so proximal type i endoleak was solved.Patient outcome: the patient did not experience any adverse effects due to this occurrence.

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.: (b)(4).Summary of investigational findings: according to the reported information the patient underwent taa repair for a shaggy aorta, and during the procedure, the proximal sealing stent was deployed bent.Subsequent angiography revealed a proximal type i endoleak.The issue was corrected with ballooning.According to the reported information, the patient did not experience any adverse effects.The imaging review did not confirm evidence of a bent stent, but confirmed a type 1a endoleak, which resolved after coda ballooning.According to the review, the endoleak was likely the result of the irregular plaque within the seal zone and perhaps seal interference from the control catheter guidewire.As per the ifu: "irregular calcification and/or plaque may compromise the attachment and sealing at the fixation sites.In the presence of anatomical limitations, a longer neck length may be required to obtain adequate sealing and fixation." no evidence to suggest that the device was not manufatured 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

Description of event according to initial reporter: an 80 year old male patient who has shaggy aorta underwent taa repair.Both right / left access route were within ifu, so right fa was chosen as main access route.First, zta-p-42-173-w1 was placed from zone 4 with normal procedure.At deployment, the stent was placed with the lesser curvature side of the proximal sealing stent bent due to function of 'pro -form tie'.So the physician performed angiography and it was confirmed that the proximal type i endoleak from the lesser curvature.He managed to fix the bent using a balloon catheter (coda, cook medical) by touch-up.The floating area of the stent was fixed so proximal type i endoleak was solved.Patient outcome: the patient did not experience any adverse effects due to this occurrence.

• 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: 7439070
• MDR Text Key: 105754422
• Report Number: 3002808486-2018-00457
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449708
• UDI-Public: (01)10827002449708(17)210131(10)E3682916
• 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: 07/02/2018

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: 01/31/2021
• Device Catalogue Number: ZTA-P-42-173-W1
• Device Lot Number: E3682916
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/03/2018
• Device Age: 3 MO
• Date Manufacturer Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR