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

Catalog Number 1012632-29

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/22/2024

Event Type  Injury  

Manufacturer Narrative

The device was not returned for 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 did not indicate a lot specific quality issue.In this case, it is likely that the device interacted with the mildly calcified, heavily tortuous, heavily stenosed lesion and previously implanted stents during advancement, as resistance was noted, causing the reported failure to advance.Interaction with the 6f (french) guide catheter, as strong resistance was noted, likely contributed to the reported difficult to advance/position due to the device not being properly supported or coaxially aligned during advancement.Further interaction with the previously implanted stents during retraction of the device likely contributed to the reported difficult to remove, ultimately causing the reported stent dislodgement.The investigation determined the reported difficulties and foreign body in patient, surgical intervention, in addition to unexpected medical intervention (additional therapy/non-surgical treatment) appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that the procedure was to treat a heavily stenosed lesion in the left common iliac artery with mild calcification and heavy tortuosity.There were two previously implanted stents in the external iliac.The 9x29mm otw omni elite balloon-expandable stent (bes) was advanced and strong resistance was noted with the 6f sheath.The bes and the sheath met strong resistance advancing in the anatomy, and the bes failed to cross to the target lesion.The bes was removed from the sheath to determine the cause of the resistance; however, during removal the bes got stuck with the edge of a previously implanted stent, the omni elite stent separated off the balloon into the left common iliac.Attempts were made for 2 hours to snare the stent, but this was unsuccessful and the patient was sent to surgery.The stent was unable to be removed with surgery; therefore, the patient was hospitalized for observation.The stent was later embedded in the arterial wall with a covered stent.There was no adverse patient sequela.No additional information was provided.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Type of Device: 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: 18713035
• MDR Text Key: 335523761
• Report Number: 2024168-2024-01878
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012632-29
• Device Lot Number: 2042041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6FR SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male