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

Catalog Number	1012631-19
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2018
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.Evaluation summary: the device was returned for analysis and visual analysis was performed.The dislodgement was confirmed.It is likely that the stent dislodgment occurred during removal due to interaction with the challenging anatomy.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 appear to be related to operational context.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 performed to treat a lesion in the mildly tortuous, heavily calcified, 90% stenosed, right external iliac artery with an 8.0 x 19 mm omnilink elite vascular stent delivery system (sds).Reportedly, the sds was advanced to the lesion and then the physician was called out of the room to attend to an emergency.It was initially decided to wait for the physician to return prior to proceeding with the procedure.Then the decision was made to remove the sds from the anatomy.During removal, the stent implant dislodged from the balloon in the vicinity of the common iliac, but remained on the unspecified guide wire.The sds was advanced, re-captured the stent and the stent was deployed partially within the target lesion.A new unspecified sds was advanced to the lesion and the stent was deployed overlapping the distal end of the omnilink elite stent by 2 to 3 mm to complete the procedure.There were no adverse patient effects and 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: 7511142
• Report Number: 2024168-2018-03542
• Device Sequence Number: 2514986
• Product Code: NIO
• UDI-Device Identifier: 08717648178498
• UDI-Public: 08717648178498
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2018

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: 09/30/2020
• Device Catalogue Number: 1012631-19
• Device Lot Number: 7040641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1