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

Catalog Number	1012625-59
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2019
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.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 investigation determined that the reported difficulties are related to circumstances of the procedure.The failure to cross and dislodgment was due to interaction with the previously implanted unspecified stent.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 the right common iliac artery through the right femoral artery.The 9.0x59mm omnilink elite stent delivery system (sds) was advanced and there was resistance noted with a previously implanted unspecified stent from a prior procedure.The omnilink elite stent dislodged from the sds.The guide wire, sds and dislodged stent were pulled into the introducer sheath and removed together as a single unit.The dislodged stent remained inside the introducer sheath outside of the patient anatomy and was then able to be removed with hemostats.A new, 8.0x59mm omnilink elite stent was used to complete the procedure.There were no adverse patient effects.There was a 40 minute delay in the procedure, but there was no effect to the patient; therefore was not considered clinically significant.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: 8250941
• Report Number: 2024168-2019-00374
• Device Sequence Number: 19192285
• Product Code: NIO
• UDI-Device Identifier: 08717648179358
• UDI-Public: 08717648179358
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/15/2019

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: 01/31/2022
• Device Catalogue Number: 1012625-59
• Device Lot Number: 8083041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR