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

Catalog Number	1012625-39
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.It was reported that the physician had commented that the stents may not have been placed kissing, and that the flow may have pushed the stent out of the lesion.The investigation determined that the reported difficulties and subsequent treatment are likely related to 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 the procedure was performed to treat bi-lateral lesions in the common iliac vessel.There was no tortuosity and no calcification on the left side and calcification of the right side.Two omni elite stents were planned for a kissing stent technique.One stent was implanted in the right common iliac without issue.The 9.0 x 39 mm omni elite stent was then implanted in the left common iliac with a good result.After the right side was closed, a guide wire was advanced to close the left side; however, it was observed that the stent on the left side had completely migrated out of the target lesion.An additional omni elite stent was implanted to secure the migrated stent.The physician commented that the stents may not have been placed kissing, and the flow may have pushed the stent out of the lesion.The patient was confirmed to be stable post procedure and no further treatment was performed.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: 7388909
• Report Number: 2024168-2018-02376
• Device Sequence Number: 196113
• Product Code: NIO
• UDI-Device Identifier: 08717648179341
• UDI-Public: 08717648179341
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 1012625-39
• Device Lot Number: 5100741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 04/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: OMNI ELITE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 59