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

Catalog Number	1012622-19
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2017
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: visual inspections were performed on the returned device.The reported stent dislodgement and flaring was confirmed.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 identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that prior to insertion into the sheath, the stent strut on the omnilink elite stent delivery system (sds) was noted to be flared.The device was replaced with a new one.There was no clinically significant delay in the procedure and no patient involvement.Returned device analysis revealed that the stent was dislodged and located on the distal shaft.Follow-up with the account confirmed that the stent dislodged when being introduced into the hemostatic valve.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: 6968557
• Report Number: 2024168-2017-08380
• Device Sequence Number: 16305859
• Product Code: NIO
• UDI-Device Identifier: 08717648179181
• UDI-Public: 08717648179181
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/23/2017

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: 06/30/2020
• Device Catalogue Number: 1012622-19
• Device Lot Number: 7011841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1