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

Model Number 1012622-39

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Device code (b)(4).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 the ominilink stent delivery system was prepped before removal of the protective sheath, and the stent came off the balloon.The device was not used, and there was no patient involvement.There was no clinically significant delay.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported stent dislodgment was 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 complaints from this lot.The device was prepped prior to removal of the protective cover.The omnilink elite instruction for use instructs to remove the protective cover from the tip prior to stent delivery system preparation.Based on the information provided, the stent dislodgment was the result of preparing the device prior to removal of the protective sheath.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• 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: 11074128
• MDR Text Key: 224059905
• Report Number: 2024168-2020-10941
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648179204
• UDI-Public: 08717648179204
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 1012622-39
• Device Catalogue Number: 1012622-39
• Device Lot Number: 8120341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1