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

Model Number	1012629-19
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923); Activation Failure (3270)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion in an unspecified artery.The 6.0 x 19 mm omni elite stent system was prepared per the instruction for use (ifu) with no issues noted and advanced but could not cross the lesion due to a sharp angulation in the vessel.Therefore, the physician decided to remove the omni elite, but when the device was pulled back there was resistance with the vessel and the stent partially deployed inside the sheath.During removal of the device, the stent dislodged completely and embolized in the groin.The patient had minor surgery to remove the dislodged stent from the groin.No additional information was provided.
Event or Problem Description
It was reported that the procedure was to treat a lesion with severe calcium in the iliac artery.The 6.0 x 19 mm omni elite stent system was prepared per the instruction for use (ifu) with no issues noted and advanced but could not cross the lesion due to a sharp angulation in the vessel.Therefore, the physician decided to remove the omni elite, but when the device was pulled back there was resistance with the vessel and the stent partially deployed inside the sheath.During removal of the device, the stent dislodged completely and embolized in the groin.The patient had minor surgery to remove the dislodged stent from the groin, prolonging hospitalization.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 revealed no other complaints reported from this lot.Based on the information provided, the reported difficulties appear to be due to circumstances of the procedure.The reported failure to advance was likely due to anatomical conditions.Additionally, the reported resistance during removal, stent partially deploying in the sheath, and dislodgment was likely the result of interaction with the sheath at the sharp angulation of the vessel.The reported patient effect of stent embolization is listed in the otw omnilink elite instructions for use (ifu) as a known potential complication associated with the use of the device.The stent embolization and minor surgery to remove the stent were related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12616298
• Report Number: 2024168-2021-09131
• Device Sequence Number: 19701264
• Product Code: NIO
• UDI-Device Identifier: 08717648179518
• UDI-Public: 08717648179518
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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: 10/31/2022
• Device Model Number: 1012629-19
• Device Catalogue Number: 1012629-19
• Device Lot Number: 9052041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown