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

Model Number	1012631-59
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual analysis was performed on the return device.The reported stent dislodgement was not confirmed; however, the stent had moved proximally on the balloon.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 complaints from this lot.Based on the reported information, the stent damage and movement on the balloon likely occurred during removal of the protective sheath, or inadvertent mishandling during preparation.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, the 8.0x59mm omnilink elite stent dislodged from the catheter.There was no patient involvement.A new unspecified device was used to continue the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: OMNILINK ELITE
• Common Device Name: PERIPHERAL STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9805377
• Report Number: 2024168-2020-02151
• Device Sequence Number: 2890565
• Product Code: NIO
• UDI-Device Identifier: 08717648178528
• UDI-Public: 08717648178528
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/09/2020

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: 01/31/2023
• Device Model Number: 1012631-59
• Device Catalogue Number: 1012631-59
• Device Lot Number: 9082341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1