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

Catalog Number ZTA-PT-44-40-179-W1

Device Problem Bent (1059)

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

Event Date 03/15/2018

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: an (b)(6) year old male patient underwent taa repair.The patients anatomical forms were suitable for the procedure.Two devices were used for the procedure: zta-pt-44-40-179-w1 / e3682927 (zone 4).Zta-de-34-112-w1 / e3677362 (zone 2).When the physician released the trigger wire of zta-pt-44-40-179-w1, the bare stent was deployed bent at approximately 90 degrees against lesser curvature of the vessel wall as if it was sticking in the vessel (vessel perforation did not occur.).He managed to fix the bent using a balloon catheter.The physician performed seven cases with using zta- product, and this was the first case to use zta- product with 'pro-form tie'.Regarding seven cases so far, there was no experience with the same occurrence such as ¿the bare stent was deployed bent at 90 degrees¿.Regarding trigger wire removal, the blue rotation handle was turned more properly than before, however, there was no help.Patient outcome: there have been no adverse effect to the patient reported.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# pr221264.G1) name and address for importer site: cook medical incorporated (cmi).400 daniels way.Bloomington, in 47404.Registration no.: 3005580113.Summary of investigational findings: as per the reported information, when the physician released the trigger wires from the system, the bare stent was deployed bent at approximately 90 degrees towards the inner aortic curvature.The reported issue was corrected using a balloon catheter.According to the reported information, there were not observed any adverse effects to the patient who had suitable anatomy for the procedure.It was not possible to determine the exact cause or a likely cause of the reported event as no imaging was provided.No evidence to suggest that the 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

Description of event according to initial reporter: an 88 year old male patient underwent taa repair.The patients anatomical forms were suitable for the procedure.Two devices were used for the procedure: zta-pt-44-40-179-w1 / e3682927 (zone 4).Zta-de-34-112-w1 / e3677362 (zone 2).When the physician released the trigger wire of zta-pt-44-40-179-w1, the bare stent was deployed bent at approximately 90 degrees against lesser curvature of the vessel wall as if it was sticking in the vessel (*vessel perforation did not occur.).He managed to fix the bent using a balloon catheter.The physician performed seven cases with using zta- product, and this was the first case to use zta- product with 'pro-form tie'.Regarding seven cases so far, there was no experience with the same occurrence such as ¿the bare stent was deployed bent at 90 degrees¿.Regarding trigger wire removal, the blue rotation handle was turned more properly than before, however, there was no help.Patient outcome: there have been no adverse effect to the patient reported.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED 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: 7395040
• MDR Text Key: 104250390
• Report Number: 3002808486-2018-00397
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002448725
• UDI-Public: (01)10827002448725(17)210131(10)E3682927
• 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: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: ZTA-PT-44-40-179-W1
• Device Lot Number: E3682927
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/16/2018
• Device Age: 2 MO
• Date Manufacturer Received: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 88 YR