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

Model Number 1012629-19

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923); Activation Failure (3270)

Patient Problem Embolism/Embolus (4438)

Event Date 09/15/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a lesion in an unspecified artery.The 6.0 x 19 mm omni elite stent system was prepared per the instruction for use (ifu) with no issues noted and advanced but could not cross the lesion due to a sharp angulation in the vessel.Therefore, the physician decided to remove the omni elite, but when the device was pulled back there was resistance with the vessel and the stent partially deployed inside the sheath.During removal of the device, the stent dislodged completely and embolized in the groin.The patient had minor surgery to remove the dislodged stent from the groin.No additional information was provided.

Event Description

It was reported that the procedure was to treat a lesion with severe calcium in the iliac artery.The 6.0 x 19 mm omni elite stent system was prepared per the instruction for use (ifu) with no issues noted and advanced but could not cross the lesion due to a sharp angulation in the vessel.Therefore, the physician decided to remove the omni elite, but when the device was pulled back there was resistance with the vessel and the stent partially deployed inside the sheath.During removal of the device, the stent dislodged completely and embolized in the groin.The patient had minor surgery to remove the dislodged stent from the groin, prolonging hospitalization.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.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 revealed no other complaints reported from this lot.Based on the information provided, the reported difficulties appear to be due to circumstances of the procedure.The reported failure to advance was likely due to anatomical conditions.Additionally, the reported resistance during removal, stent partially deploying in the sheath, and dislodgment was likely the result of interaction with the sheath at the sharp angulation of the vessel.The reported patient effect of stent embolization is listed in the otw omnilink elite instructions for use (ifu) as a known potential complication associated with the use of the device.The stent embolization and minor surgery to remove the stent were related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 12616298
• MDR Text Key: 275922870
• Report Number: 2024168-2021-09131
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648179518
• UDI-Public: 08717648179518
• 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: 11/08/2021

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 Expiration Date: 10/31/2022
• Device Model Number: 1012629-19
• Device Catalogue Number: 1012629-19
• Device Lot Number: 9052041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 10/15/2021
• Supplement Dates FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2019
• 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): Hospitalization; Required Intervention