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

Catalog Number	1012626-29
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2018
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.Concomitant medical products: guide wire: treasure floppy 18, radifocus; sheath: glidesheath slender 7fr.(b)(4).A visual, dimensional and functional inspection was performed on the returned device.During dimensional and functional testing of the returned unit, the reported difficulty was not confirmed.The sds was removed from the non-abbott (7f) introducer sheath with no resistance noted.Additionally, there was no resistance noted while advancing the sds through the non-abbott (7f) introducer sheath.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 of the reported lot revealed no other incidents.The investigation was unable to determine a conclusive cause for the reported difficulties.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 treat a de novo lesion in a mildly tortuous subclavian vein that was 90% stenosed.A glidesheath was inserted in the left brachial artery and a.018 non-abbott guide wire crossed the lesion.Then the guide wire was replaced with a.035 non-abbott guide wire, and pre-dilatation was performed with a 9.0 x 20 mm non-abbott balloon dilatation catheter.A 10 x 29 mm omnilink elite vascular balloon-expandable stent was implanted; however, there was difficulty in removing the device from the introducer sheath.Therefore, the delivery system was removed with the sheath as a single unit.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: 7938786
• Report Number: 2024168-2018-07701
• Device Sequence Number: 1998711
• Product Code: NIO
• UDI-Device Identifier: 08717648179372
• UDI-Public: 08717648179372
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/05/2018

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: 01/31/2019
• Device Catalogue Number: 1012626-29
• Device Lot Number: 5081341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1