MAUDE Adverse Event Report: ABBOTT VASCULAR OMNILINK ELITE PERIPHERAL STENT SYSTEM; PERIPHERAL STENT DELIVERY SYSTEM

Model Number	1012631-29
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to abbott vascular for analysis.A query of the complaint handling system database for the reported lot revealed no other similar incidents and/or complaints reported for stent dislodgement.Return of the stent delivery system may have further aided the analysis.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 identified no other incidents reported from this lot.Factors that can contribute to stent dislodgement include, but not limited to; improper or inadequate crimping at the time of manufacture, incorrect sheath sizing, positive pressure during preparation, forced sheath removal, handling of the stent during preparation, and interaction with the lesion, accessory devices, and/or previously implanted stents.To ensure this is not the result of a manufacturing issue, all sds are inspected for proper stent placement, stent damage and crimped stent outer diameter.The investigation was unable to determine a conclusive cause for the reported stent movement.There is no indication of a product quality issue with respect to the design, and manufacture of the device.Na.
Event or Problem Description
It was reported that during preparation, the 8x29mm omnilink elite vascular balloon-expandable stent system (bes) was removed from the packaging and after removal of the protective sheath, the end of the stent was loose on the balloon.The bes was discarded, and another device was used to successfully complete the procedure.There was no patient involvement 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 DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10551559
• Report Number: 2024168-2020-07829
• Device Sequence Number: 3528482
• Product Code: NIO
• UDI-Device Identifier: 08717648178504
• UDI-Public: 08717648178504
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial
• Report Date (Section B): 09/17/2020

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: 12/31/2022
• Device Model Number: 1012631-29
• Device Catalogue Number: 1012631-29
• Device Lot Number: 9070341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1