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

Catalog Number	1012632-29
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/30/2016
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 stent remains in the vessel.The delivery system 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.The investigation determined that the reported difficulties are related to circumstances of the procedure.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.
Event or Problem Description
It was reported that during the procedure of the non-tortuous, non-calcified, iliac artery a 6 fr slender sheath was used and after pre-dilatation of the vessel the omnilink elite stent delivery system (sds) was attempted but failed to cross the lesion.During removal of the sds, the stent dislodged in the arm at the distal end of the sheath.The procedure was continued with a smaller size stent successfully deployed in the target lesion.A balloon catheter was then advanced distal to the dislodged stent, but was unsuccessful in removal and the stent was expanded to the vessel wall.There was no reported adverse patient sequela.There was 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: 6017310
• Report Number: 2024168-2016-06828
• Device Sequence Number: 510333
• Product Code: NIO
• UDI-Device Identifier: 08717648178542
• UDI-Public: (01)08717648178542(17)180531(10)4121641
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 10/11/2016

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 1012632-29
• Device Lot Number: 4121641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2016
• Initial Report FDA Received Date: 10/11/2016
• 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: 6FR SLENDER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention