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

Model Number	G43841
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Nio stent, iliac.
Event or Problem 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: 11999836
• Report Number: 3005580113-2021-00071
• Device Sequence Number: 4306023
• Product Code: NIO
• UDI-Device Identifier: 10827002438412
• UDI-Public: (01)10827002438412(17)190122(10)CR1202156
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2021
• Report Date (Section F): 06/15/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2019
• Device Model Number: G43841
• Device Catalogue Number: ZIV6-35-125-10-40
• Device Lot Number: CR1202156
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 54
• Date Report Sent to FDA: 06/15/2021