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

Model Number 1012630-59

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

Patient Problem Foreign Body In Patient (2687)

Event Date 05/03/2023

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 identified no other incidents.The reported difficulties and subsequent unexpected medical intervention including foreign body in patient appear to be related to the operational context 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 mildly calcified, moderately tortuous, 100% stenosed lesion in the left common iliac artery.Access was gained via the left common femoral artery and pre-dilatation was performed.A 7.0x59mm omni elite balloon-expandable stent (bes) was then advanced, however it could not cross the challenging anatomy and had to be withdrawn.During removal from the anatomy, the stent came off the delivery balloon due to resistance with the calcium or tortuosity and was partially in the common iliac that was to be treated and partially outside of the target lesion.The omni elite balloon was used to partially embedded the dislodged stent in the common iliac and the remainder of the stent was out of the target lesion.A 7.0x29mm omnilink elite stent was then deployed overlapping the first stent to cover the remainder of the lesion and secure the dislodged stent.There were no reported adverse patient effects and no clinically significant delays in the procedure.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: 16985418
• MDR Text Key: 315819815
• Report Number: 2024168-2023-05491
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648178481
• UDI-Public: 08717648178481
• 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: 05/23/2023

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
• Device Operator: Health Professional
• Device Model Number: 1012630-59
• Device Catalogue Number: 1012630-59
• Device Lot Number: 2091341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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: 6F SHEATH (TERUMO).
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 63 KG