MAUDE Adverse Event Report: AV-TEMECULA-CT OMNILINK ELITE PERIPHERAL STENT SYSTEM

Catalog Number	1012626-39
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation determined the reported difficulties appear to be related to operational context.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Event or Problem Description
It was reported that a non-abbott stent graft was implanted in the abdominal aortic aneurysm.The stent graft was not fully inflated and part of the graft bent.The 10x39 mm omnilink elite stent was inserted through the radial access site into the stent graft to reinforce the graft, but the omnilink stent dislodged from the delivery system during positioning.The omnilink elite stent was deployed at an unintended vessel in the external iliac artery (eia) using a non-abbott balloon through a femoral access site.Another stent was implanted inside the stent graft and the procedure was completed.There was no report of a clinically significant delay in the procedure and no patient effect caused by the device.No additional information was provided.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Common Device Name: PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6613548
• Report Number: 2024168-2017-04796
• Device Sequence Number: 10889443
• Product Code: NIO
• UDI-Device Identifier: 08717648179389
• UDI-Public: (01)08717648179389(17)180331(10)4103141
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 1012626-39
• Device Lot Number: 4103141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2017
• Initial Report FDA Received Date: 06/05/2017
• 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 Age: 87 YR