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

Catalog Number	1012623-29
Medical Device Problem Codes	Off-Label Use (1494); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.Lhr (lot history record) and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other incidents from this lot.It was reported that the procedure was to treat the subclavian artery.It should be noted that the omnilink elite instructions for use states: 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.The investigation was unable to determine a conclusive cause for the reported stent dislodgement.Reportedly, the dislodged omnilink elite stent could not be retrieved with an unspecified guide wire.The stent was pushed distally into a branch off the internal iliac artery where the vessel size matched the stent size.The stent was not inflated.The reported foreign body in patient and unexpected medical intervention appears to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6- medical device problem code 1494 clarifier: incorrect anatomy.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the subclavian artery with access thru the right common femoral artery (cfa).The omnilink elite 35 7.0mmx29mmx80cm stent delivery system (sds) felt no resistance advancing to the lesion; however, once the delivery system reached the target lesion, the stent size was deemed too long for the lesion.Therefore, the undeployed stent and sds were withdrawn with no resistance noted, but the stent dislodged in the internal iliac artery.An unsuccessful retrieval was attempted with an unspecified 0.014 guide wire.The stent was then pushed distally into an unspecified collateral artery branch off the internal iliac artery where the vessel size matched the stent size.The stent was not inflated.The procedure was continued with implant of a 6x29mm omnilink stent to treat the target lesion in the subclavian artery.There was no adverse patient sequela.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: 19093226
• Report Number: 2024168-2024-04603
• Device Sequence Number: 17910275
• Product Code: NIO
• UDI-Device Identifier: 08717648179259
• UDI-Public: (01)08717648179259(17)250930(10)2041441
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 04/11/2024

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: 09/30/2025
• Device Catalogue Number: 1012623-29
• Device Lot Number: 2041441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2022
• 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 Age: 44 YR
• Patient Sex: Female
• Patient Weight: 72 KG