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

Catalog Number	1012624-39
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/08/2019
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.A visual inspection was performed and it was noted that the stent had moved from its position on the balloon.The reported kinked tip was unable to be 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 of the reported lot revealed no other similar incidents reported for the lot.The investigation determined the reported kinked tip appears to be related to operational circumstances of the procedure.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 during preparation, it was noted that the tip of an 8.0 x 39 mm omnilink elite vascular balloon expandable stent system was kinked.Therefore, the stent system was replaced with an unspecified device to successfully complete the procedure.There were no patient involvement.No additional information was provided.Returned device analysis revealed that the stent had moved from its position on the balloon.

• 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: 8744935
• Report Number: 2024168-2019-05214
• Device Sequence Number: 11182447
• Product Code: NIO
• UDI-Device Identifier: 08717648179303
• UDI-Public: 08717648179303
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2019

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: 04/30/2022
• Device Catalogue Number: 1012624-39
• Device Lot Number: 8111541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1