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

Catalog Number	1012625-29
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted, because the lot number was not provided.It should be noted that the omni elite instructions for use states: when treating multiple lesions, the distal lesion should be initially stented, followed by stenting of the proximal lesion.Stenting in this order obviates the need to cross the proximal stent in placement of the distal stent and reduces the chances for dislodging the stent.The investigation determined the reported difficulties to be related to user error as a deviation to the ifu contributed to the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The other omnilink elite referenced in describe event or problem and concomitant medical products is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified right external iliac artery.It was a contralateral approach.A 9.0 x 29 mm omnilink elite stent was deployed in the lesion.A second 9.0 x 29 mm omnilink elite stent delivery system was being advanced through the previously placed stent when there was resistance with the tip and the deployed stent, and the deployed stent compressed approximately 10 mm at the proximal end.The second stent was deployed distally to the first stent.A third stent was deployed proximal to the first stent to cover the area where the stent compressed.There was no clinically significant delay in procedure.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: 6265314
• Report Number: 2024168-2017-00574
• Device Sequence Number: 1003305
• Product Code: NIO
• UDI-Device Identifier: 08717648179334
• UDI-Public: (01)08717648179334
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/19/2017

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: 1012625-29
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2017
• Initial Report FDA Received Date: 01/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: OMNILINK ELITE
• Patient Age: 75 YR