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

Catalog Number	1012629-59
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	06/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of pain is a known observed and potential patient effect as listed in the omnilink elite electronic instructions for use.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.
Event or Problem Description
It was reported that the three omnilink elite stents were implanted from the left iliac to the right iliac artery on (b)(6) 2016.After the procedure, the patient had back pain.Several weeks later, the patient had swelling in her legs.The doctor prescribed her prednisone for the back pain, but it has not helped.A week after that, she began having left leg pain to the point where she is unable to stand on the left leg.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 OK 92591 4628
• MDR Report Key: 5940898
• Report Number: 2024168-2016-05989
• Device Sequence Number: 13646756
• Product Code: NIO
• UDI-Device Identifier: 08717648179549
• UDI-Public: (01)08717648179549(17)190630(10)6011841
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: consumer
• Initial Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2016

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 1012629-59
• Device Lot Number: 6011841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2016
• Initial Report FDA Received Date: 09/09/2016
• 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 (X2)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR
• Patient Weight: 58