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

Model Number 1012625-29

Device Problems Leak/Splash (1354); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received.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 performed to treat a lesion with mild tortuosity and 90% stenosis in the right common iliac artery.A 9.0 x 29 mm otw omni elite balloon-expandable stent (bes) was advanced to the target lesion, however, during the balloon inflation, a leak was noted from the connection between the hub and the shaft.Therefore, the pressure could not be applied smoothly, and the stent was difficult to deploy.With nominal pressure, the stent was successfully implanted in the target lesion.There were no adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual and functional analysis was performed on the return device.The reported leak was confirmed.The deployment issue was a result of the leak and was not tested as the stent was not returned.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.Based on the information provided and analysis of the returned unit, a definitive cause for the reported difficulties could not be determined.It may be possible that the shaft of the omnilink elite was inadvertently pulled during removal from the dispenser coil or other mishandling during preparation causing the outer member to become displaced within the sidearm resulting in delamination of the adhesive causing the leak noted at the strain relief.However, 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: 10602933
• MDR Text Key: 209177068
• Report Number: 2024168-2020-08105
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648179334
• UDI-Public: 08717648179334
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 1012625-29
• Device Catalogue Number: 1012625-29
• Device Lot Number: 7092141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: RADIFOCUS 0.035; SHEATH: DESTINATION 6FR 45CM.