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

Catalog Number	1012624-29
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	05/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.However, factors that can contribute to the stent separating post procedure include, but are not limited to, improper or inadequate placement of the stent implant, damaged stent during procedure, post dilatation technique.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported stent separation and patient effects.The reported patient effects of device embedded within the vessel is listed in the omnilink elite instructions for use as a known patient effect that may be associated with use of a peripheral stent in native peripheral arteries.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 on (b)(6) 2017 was to treat lesions in the left and right common iliac arteries.An 8x29mm omnilink elite stent and a second unknown omnilink elite stent were implanted in the bifurcation.The patient was readmitted on (b)(6) 2017.About one third of the 8x29mm stent implanted on the right side of the bifurcation broke off and migrated to the distal right external artery.An absolute pro stent was implanted to jail the broken piece against the artery wall.Post-dilatation was performed with a 7.0x60mm armada 35 balloon catheter successfully.There was no clinically significant delay in the 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: 6599849
• Report Number: 2024168-2017-04602
• Device Sequence Number: 943829
• Product Code: NIO
• UDI-Device Identifier: 08717648179297
• UDI-Public: (01)08717648179297(17)190531(10)5122141
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/30/2017

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: 05/31/2019
• Device Catalogue Number: 1012624-29
• Device Lot Number: 5122141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 05/30/2017
• 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: Hospitalization; Required Intervention