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

Model Number	1012632-29
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual analysis was performed on the return device.The reported stent dislodgement was confirmed.The difficulty removing could not be tested due to the condition of the returned device.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 and/or complaints from this lot.Based on the information provided, the reported difficulties appear to be due to circumstances of the procedure.The difficulty removing, and stent dislodgement was likely the result of the omnilink elite stent catching on the distal end of the introducer sheath during withdrawal.It is likely that the angle of the sheath in the anatomy caused the proximal struts of the stent to interact with the tip of the introducer sheath.The additional treatment to deploy the dislodged stent in the target lesion was related to case circumstances.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 performed to treat a lesion in the common iliac artery.A 9.0x29mm otw omni elite stent delivery system was advanced through a 6fr sheath; however, it was pulled back to take more pictures and the stent met resistance with the sheath and the stent dislodged.The stent remained on the guide wire; therefore, the delivery system was removed.A smaller unspecified balloon catheter was advanced and was able to advance the dislodged stent to the target lesion and deploy the stent against the vessel walls.The smaller balloon catheter was removed and the otw omni elite delivery system was re-advanced to fully deploy the stent.The procedure was successfully completed.There were no adverse patient sequela 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: 9923226
• Report Number: 2024168-2020-03355
• Device Sequence Number: 19651458
• Product Code: NIO
• UDI-Device Identifier: 08717648178542
• UDI-Public: 08717648178542
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2020

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: 09/30/2021
• Device Model Number: 1012632-29
• Device Catalogue Number: 1012632-29
• Device Lot Number: 8040341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 68