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

Catalog Number	1012626-59
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2018
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 analysis.The lot history record for this product could not be reviewed and a similar incident query could not be performed because the lot number was not reported.The otw omnilink elite instructions for use states: pre-dilate the lesion with an appropriate size balloon dilatation catheter to closely match the lumen diameter proximal and distal to the lesion.The investigation determined the resistance and stent movement (unstable stent) was due to operational context.It is likely that failing to pre-dilate the lesion prior to advancing the omnilink elite contributed to the difficulties.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 the procedure was to treat a moderately calcified common iliac artery and plaque at the ostium was noted.Pre-dilatation was not performed.A 10x59 mm omnilink elite stent delivery system (sds) was advanced slightly past the lesion and when pulling the sds back, resistance was felt with the anatomy and the stent partially came off the balloon approximately 5mm.The physician made the decision to deploy the stent at that location to prevent dislodgement of the stent.The stent was partially in the lesion and partially in healthy tissue.A 10x29 mm omnilink elite stent was implanted to successfully treat the remaining portion of the lesion.There was no adverse patient effect and no reported clinically significant delay in the 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: 8209503
• Report Number: 2024168-2019-00015
• Device Sequence Number: 13504723
• Product Code: NIO
• UDI-Device Identifier: 08717648179396
• UDI-Public: 08717648179396
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/02/2019

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: 1012626-59
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 01/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR