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

Catalog Number	1012624-19
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Incorrect anatomy.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 reported for this lot.The omnilink elite vascular balloon expandable stent system electronic instructions for use (ifu) states: the system is indicated for the treatment of atherosclerotic iliac artery lesions.The violation of the ifu does not appear to have contributed to the reported stent movement.The investigation was unable to determine a conclusive cause for the reported unstable stent implant.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 patient underwent a procedure to treat a target lesion in the moderately calcified left subclavian artery.The 8.0 x 19 mm omnilink elite vascular stent delivery system was advanced; however, during positioning, the stent started to come off the delivery system balloon.As the stent was still partially on the delivery system balloon, the physician was able to pull the delivery system back a bit and get the stent mostly centered back on the balloon.The stent delivery system balloon was then inflated to 1.5 atmospheres (atm) to secure the stent to the balloon.The stent delivery system was then advanced to the target lesion and deployed at the desired location.Post procedure, the patient was doing well.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: 7430801
• Report Number: 2024168-2018-02786
• Device Sequence Number: 2156899
• Product Code: NIO
• UDI-Device Identifier: 08717648179280
• UDI-Public: 08717648179280
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2018

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: 11/30/2020
• Device Catalogue Number: 1012624-19
• Device Lot Number: 7060341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/13/2018
• 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
• Patient Age: 66 YR