MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 VASCULAR SELF-EXPANDING STENT

Model Number G43826

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

Nio stent, iliac.

Event Description

This patient has had numerous cts and a total of 4 secondary interventions throughout participation in this study.To simplify these cts (as related to this event), please see the table uploaded as an attached file the table provides the date of the imaging, the number of days post-procedure, the maximum aneurysm diameter and presence of an endoleak (as reported by the clinical study site or the core laboratory).Also included is the secondary interventions, the indication for them and the treatments.A ct dated (b)(6) 2021 revealed an enlarging aneurysm.The clinical study site was unable to identify an endoleak and reported the maximum aneurysm diameter was 73mm.The core laboratory evaluation of the ct identified a definite endoleak but the source could not be determined and was listed as an unknown endoleak.A second ct scan dated (b)(6) /2021 was completed.The site again could not identify an endoleak, but continued aneurysm enlargement, now 77mm, led the site to schedule a secondary intervention.Core laboratory evaluation of the ct again revealed an unknown type endoleak.On (b)(6) 2021 (1705 days post-procedure) the patient underwent a secondary intervention to place a proximal aortic cuff extension as well as a left iliac stent graft extension with kissing stents in the left external and internal iliac arteries.Per op-note ¿presumed type 1a and 1b endoleak¿ treated with placement of (36 mm medtronic) proximal aortic cuff extension, distal left iliac stent graft extension (with a 9 x 59 vbx gore stent into the left internal iliac and a 9mm x 79 mm vbx gore stent in the left external iliac artery).The secondary intervention was considered successful.Post procedure angiography revealed the devices were patent with no endoleak or device integrity issues noted.No aortogram was submitted for core laboratory evaluation.

• Brand Name: ZILVER 635 VASCULAR SELF-EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11998318
• MDR Text Key: 267548053
• Report Number: 3005580113-2021-00070
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002438269
• UDI-Public: (01)10827002438269(17)181201(10)C1177251
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2021,06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2018
• Device Model Number: G43826
• Device Catalogue Number: ZIV6-35-125-7-40
• Device Lot Number: C1177251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2021
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 54