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

Catalog Number 11005-29

Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Material Deformation (2976)

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

Event Date 05/04/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received but is pending evaluation.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a moderately tortuous, moderately calcified superficial femoral artery that was 90% stenosed.Pre-dilatation was performed.Then a 9x29mm omnilink stent was advanced through the 6fr sheath, but much resistance was met.Therefore, the omnilink was removed out of the sheath and it was then noted that the stent struts were flared and had slid off the balloon a bit (still remaining on the delivery system).An unspecified stent expandable system was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned omnilink elite.The difficulty advancing the omnilink elite through a 6fr sheath was unable to be confirmed due to the condition of the returned unit.The reported stent dislodgement and stent damage were confirmed as the stent was moved proximally on the balloon and distal end of the stent struts were bent and flared.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 complaints reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.The introducer sheath used in this case was not returned; therefore, the exact inner diameter was unable to be determined.It may be possible that the inner diameter of the non-abbott 6fr introducer sheath was smaller than the recommended diameter of 0.085 inches (2.15 mm) as indicated on the omnilink elite product label; however, without having the sheath to examine, this could not be confirmed.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: 11856060
• MDR Text Key: 251732104
• Report Number: 2024168-2021-04248
• Device Sequence Number: 1
• Product Code: NIO
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 11005-29
• Device Lot Number: 0111241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 0.035 GUIDE WIRE; LONG DESTINATION SHEATH 6 FR; 0.035 GUIDE WIRE; LONG DESTINATION SHEATH 6 FR