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

Catalog Number	1012629-39
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2017
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.(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 omnilink elite instruction for use (ifu) states: do not attempt to pull an unexpanded stent back through the introducer sheath / guiding catheter; dislodgment of the stent from the balloon may occur.The dislodgment likely occurred due to the ifu deviation.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 manufacture, design or labeling.
Event or Problem Description
It was reported that during a moderately calcified, heavily tortuous left subclavian artery intervention, the 6.0 x 39 omnilink elite stent delivery system (sds) was unable to cross through a previously implanted stent and get to the lesion.The sds was removed from and re-inserted into the anatomy three times.After the last removal and re-insertion, the stent was no longer on the delivery system and could not be located, but it was suspected to have dislodged inside the 7 french sheath.There was no adverse patient sequela or a 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: 6985660
• Report Number: 2024168-2017-08526
• Device Sequence Number: 11069570
• Product Code: NIO
• UDI-Device Identifier: 08717648179532
• UDI-Public: 08717648179532
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/27/2017

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: 04/30/2020
• Device Catalogue Number: 1012629-39
• Device Lot Number: 6112341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1