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

Catalog Number	1012625-39
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	02/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.Possible factors that may contribute to difficult to position through an introducer sheath may include, but are not limited to: damage to the stent, damaged to the device, damage to the introducer sheath.In this case, it is possible that the outer diameter of the introducer sheath may have been too large that during advancement the introducer sheath encountered resistance and/or became entrapped with the previously implanted stent resulting in the reported stretched stent implant; however, this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported difficult to position.The reported material deformation and additional therapy non-surgical treatment appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified lesion in the right common iliac artery.A 9x39mm omni elite stent was deployed in the right common iliac artery; however, a sheath was being advanced through the stent to obtain left access and the sheath became stuck with the stent.The stent migrated and elongated towards the left common iliac artery and aorta bifurcation.The procedure was successfully completed by using two unknown kissing stents to smash the omnilink elite stent against the vessel wall.There was no clinically significant delay in the procedure and no adverse patient effects.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: 7308279
• Report Number: 2024168-2018-01502
• Device Sequence Number: 19395493
• Product Code: NIO
• UDI-Device Identifier: 08717648179341
• UDI-Public: 08717648179341
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2018

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: 02/28/2021
• Device Catalogue Number: 1012625-39
• Device Lot Number: 7090441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 03/01/2018
• 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