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

Catalog Number	1012629-29
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2017
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.Visual inspection was performed on the returned device.The stent damage was confirmed.It is likely that the omnilink elite was not properly aligned during insertion into the sheath causing the stent damage.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 revealed no other incidents.The investigation determined that the reported difficulties were due to case circumstances.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 an 80% stenosed and heavily calcified lesion in the iliac artery.It was noticed that the stent of a 6x29mm omni elite unraveled (flared) while attempting to insert it into the sheath.It was confirmed that the stent did not dislodge; however, the specific stent damage could not be confirmed.The procedure was successfully completed with a new omni elite stent.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.The return device analysis found that the stent was stretched out and dislocated on the balloon yet stationary, with the proximal end of stent at 12.5mm proximal to distal balloon marker.

• 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: 7311214
• Report Number: 2024168-2018-01538
• Device Sequence Number: 1475468
• Product Code: NIO
• UDI-Device Identifier: 08717648179525
• UDI-Public: 08717648179525
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/02/2018

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: 12/31/2020
• Device Catalogue Number: 1012629-29
• Device Lot Number: 7073141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 60