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

Catalog Number	1012626-39
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(40.During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.Obtaining the device may have further aided the analysis.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported difficulty.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
Reportedly, a 10x39mm otw omnilink elite balloon-expandable stent system was removed from the dispenser coil; however, it was noticed that the stent was loose.No resistance removing the device from the dispenser coil was felt.The procedure was successfully completed with a new otw omnilink elite balloon-expandable stent system.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: 6734172
• Report Number: 2024168-2017-06105
• Device Sequence Number: 1412308
• Product Code: NIO
• UDI-Device Identifier: 08717648179389
• UDI-Public: 08717648179389
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1012626-39
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1