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

Model Number 1012624-19

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923); Material Deformation (2976)

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

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for investigation.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 left subclavian artery.An 8.0x19mm otw omnilink elite stent delivery system was attempted to be advanced through an unspecified stent in an attempt to treat a lesion distally; however, met resistance with the unspecified implanted stent and became crumpled.The stent dislodged but remained on the shaft and was simply withdrawn.There was no adverse patient effects no clinically significant delay.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the return device.The reported failure to advance and difficulty removing were not confirmed as it was related to procedural conditions.The stent damage and dislodgement were confirmed.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 and/or complaints reported from this lot.It should be noted that the omnilink elite instruction for use (ifu) states: when treating multiple lesions, the distal lesion should be initially stented, followed by stenting of the proximal lesion.Stenting in this order obviates the need to cross the proximal stent in placement of the distal stent and reduces the chances for dislodging the proximal stent.Although it was reported that the omnilink elite stent delivery system was attempted to be advanced through an unspecified stent which likely contributed to the difficulties, it may be possible that lesion site was assessed after placement of the first stent and determined that the lesion required an additional stent to be placed distally.Based on the information provided, the reported difficulties appear to be due to circumstances of the procedure.It is likely that the reported failure to advance and stent damage were due to interaction with the previously implanted stent.Additionally, after the failed attempt to advance through the previously implanted stent, it is likely that the stent became damaged and compromised on the balloon such that during removal, the stent dislodged from the balloon.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
• MDR Report Key: 12020399
• MDR Text Key: 258902138
• Report Number: 2024168-2021-05107
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648179280
• UDI-Public: 08717648179280
• Combination Product (y/n): N
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 1012624-19
• Device Catalogue Number: 1012624-19
• Device Lot Number: 0032641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 61