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

Model Number 1012633-39

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

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

Event Date 04/05/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion in an unspecified artery.The 10.0x39mm omnilink elite stent delivery system (sds) was being advanced in the 6french (fr) sheath when it got stuck about 5-10cm inside the sheath.The 6fr sheath and sds were removed.The sheath was exchanged for a 7fr sheath and another omnilink elite stent was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents.The investigation was unable to determine a conclusive cause for the reported difficult to advance and difficult to remove.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 16809824
• MDR Text Key: 313954548
• Report Number: 2024168-2023-04304
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648178597
• UDI-Public: 08717648178597
• 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
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012633-39
• Device Catalogue Number: 1012633-39
• Device Lot Number: 2120141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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
• Treatment: 6FR SHEATH