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

Catalog Number UNK OMNILINK ELITE

Device Problems Off-Label Use (1494); Stretched (1601); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2023

Event Type  Injury  

Manufacturer Narrative

D4: the udi is unknown because the part/lot number were not provided.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat a lesion in the subclavian artery with 95% stenosis and calcification.Access site was the forearm.The omnilink elite stent delivery system (sds) had resistance at the access site and failed to cross due to the anatomy.The stent came off the balloon due to the sheath being frayed from the calcium.The stent was retrieved after a balloon was advanced past the stent, expanded the balloon then pulled back and grabbed the dislodged stent with hemostats.Although there was a delay in the procedure, there was no adverse patient effect, therefore, the delay did not result in patient harm.The procedure was aborted and the patient will return for the treatment.No additional information was provided.

Manufacturer Narrative

D4: the udi is unknown because the part/lot number were not provided.H6: medical device problem code - incorrect anatomy.The device was returned for analysis.The reported stent dislodgement was confirmed.The reported failure to advance could not be replicated in a testing environment as it was related to operational context of the procedure.A review of the electronic lot history record (elhr) and lot level similar incident query for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.The investigation determined the reported difficulties and 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.It was reported that the procedure was to treat a lesion in the subclavian artery with 95% stenosis and calcification.Access site was the forearm.It should be noted that the omnilink elite instructions for use (ifu) 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.' it is unknown if the ifu deviation contributed to the reported event.H6: medical device problem code 1601 removed; 1494 added.

Event Description

It was reported that the procedure was to treat a lesion in the subclavian artery with 95% stenosis and calcification.Access site was the forearm.The omnilink elite stent delivery system (sds) had resistance at the access site and failed to cross due to the anatomy.The stent came off the balloon due to the sheath being frayed from the calcium.The stent was retrieved after a balloon was advanced past the stent, expanded the balloon then pulled back and grabbed the dislodged stent with hemostats.There was no adverse patient effect.Although there was a delay in the procedure, there was no adverse patient effect, therefore, the delay did not result in patient harm.The procedure was aborted and the patient will return for the treatment.

• 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: 18476976
• MDR Text Key: 332453550
• Report Number: 2024168-2024-00451
• 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,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK OMNILINK ELITE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention