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

Catalog Number	1012630-59
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2016
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.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.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Based on the information provided, the reported difficulties appear to be due to operational circumstances of the procedure.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified common iliac artery.A 7.0 x 59 mm omni elite self-expanding stent system ruptured during the first inflation at 11 atmospheres.The device was prepped prior to the procedure per the instructions for use.The stent remained on the balloon and was removed without issue.Another omni elite was successfully used to complete the procedure.There was no clinically significant delay in 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: 5854887
• Report Number: 2024168-2016-05234
• Device Sequence Number: 16545067
• Product Code: NIO
• UDI-Device Identifier: 08717648178481
• UDI-Public: (01)08717648178481(17)181130(10)5060241
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 08/08/2016

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 Expiration Date: 11/30/2018
• Device Catalogue Number: 1012630-59
• Device Lot Number: 5060241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2016
• Initial Report FDA Received Date: 08/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1