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

Model Number 1012630-29

Device Problem Malposition of Device (2616)

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

Event Date 04/25/2022

Event Type  malfunction  

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 determined the reported malposition of device (stent) appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that the procedure was to treat a lesion located in the superior mesenteric artery.The 7x29mm otw omni elite stent was advanced to the lesion, but during deployment, the stent jumped distally and only partially covered the lesion.Another omnilink stent was implanted to fully cover the lesion.There was no adverse patient effect or a clinically significant delay in procedure.

• 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: 14366194
• MDR Text Key: 291829123
• Report Number: 2024168-2022-05173
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648178467
• UDI-Public: 08717648178467
• 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: 05/11/2022

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: 1012630-29
• Device Catalogue Number: 1012630-29
• Device Lot Number: 1100841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2021
• 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
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 69 KG