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

Catalog Number	1012631-59
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	06/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.The investigation determined the reported difficulties and additional treatment appear to be related to operational context.It is likely that difficulty removing and stent dislodgment was due the stent becoming lodged within the heavily diseased lesion and dislodging during the attempt to remove.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 was to a lesion in the external iliac artery.An unknown guide wire was advanced into the internal iliac artery and an 8x59mm otw omni elite stent system was advanced over the wire.Loss of support with the sheath was felt so it was advanced and at the same time the stent system was also advanced about 8mm into the incorrect artery.The internal iliac artery was heavily disease and caused the stent to become stuck.Force was used to remove the stent system, but the stent dislodged and only the stent system was removed.An attempt to snare the stent was made, but it was lodged in the artery.The right common femoral artery was accessed and the stent was crushed against the vessel wall.An unspecified otw omni elite stent was placed over the crushed stent.The procedure was successfully completed with the deployment of an unspecified absolute pro stent in the external iliac artery.There was no 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: 7648912
• Report Number: 2024168-2018-05115
• Device Sequence Number: 14062213
• Product Code: NIO
• UDI-Device Identifier: 08717648178528
• UDI-Public: 08717648178528
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/28/2018

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: 1012631-59
• Device Lot Number: 7061641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 06/28/2018
• 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: 67 YR
• Patient Weight: 111