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

Model Number	1012622-16
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat an unknown lesion.The 6.0x16mm omnilink 18 balloon expandable stent (bes) was placed in the renal artery; however, the physician decided that the herculink stent with a 014 guide wire will be a better fit.Therefore, the omnilink was removed and when was out of the anatomy, the stent was not in the balloon.The stent was found in the aorta; therefore, a snared device was used to retrieved the stent.Another herculink with a.01 guide wire was used to complete the procedure.There were no adverse patient sequela and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: device code 1494 clarifier- incorrect anatomy.H6: device code 2017 clarifier- failure to follow steps / instructions.
Additional Manufacturer Narrative
A visual inspection was performed on the returned stent.The reported stent dislodgement was confirmed.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.The investigation was unable to determine a conclusive cause for the reported stent dislodgement; however, the subsequent treatment of unexpected medical intervention (additional therapy/non-surgical treatment) appear to be related to the operational context of the procedure.It was reported that the 6.0x16mm omnilink 18 balloon expandable stent (bes) was intended for use in the renal artery.It should be noted that the omnilink elite instructions for use (ifu) state that the omnilink elite stent system is indicated for the treatment of atherosclerotic iliac artery lesions with reference vessel diameters of = 5.0 mm and = 11.0 mm, and lesion lengths up to 50 mm.It is unknown if the ifu deviation contributed to the reported event.It was reported the physician decided the omnilink would be a better fit with a.014 guide wire instead of the 035 wire.When the omnilink was removed from the patient and outside the anatomy, it was noted the stent was not on the balloon.It should be noted that the omnilink elite ifu, do not attempt to pull an unexpanded stent back through the introducer sheath/ guiding catheter; dislodgment of the stent from the balloon may occur.It is unknown if the ifu deviation contributed to the reported event.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
Subsequent to the initially filed report, the account stated that the bes was intended for use in the renal artery; however, was withdrawn prior deployment.Returned device analysis identified, the stent delivery system (sds) was not included with the rest of the device; however, the account stated that the sds was discarded.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
• 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: 17120357
• Report Number: 2024168-2023-06200
• Device Sequence Number: 15115869
• Product Code: NIO
• UDI-Device Identifier: 08717648179174
• UDI-Public: 08717648179174
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/09/2023

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: 05/31/2025
• Device Model Number: 1012622-16
• Device Catalogue Number: 1012622-16
• Device Lot Number: 1120141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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: Required Intervention
• Patient Sex: Unknown