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

Catalog Number UNK OMNILINK ELITE

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: estimated date.The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported in a general comment that an omnilink elite stent became stuck inside the sheath during advancement.The omnilink elite was removed from the patient together with the sheath and a new larger sheath and omnilink elite stent were used to complete the procedure.There were no reported adverse patient effects.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.Product performance engineering reviewed the incident information; however, the products were not returned to abbott vascular for analysis.Return of the stent deliver system (sds) and introducer sheath may have further aided the analysis.A review of the lot history record and similar incident query for this product was not performed since the part and lot numbers were not reported.Potential factors for resistance with between the omnilink elite and the introducer sheath include, but are not limited to, manufacturing, incorrect size sheath used, damage to the stent, damage to the introducer sheath, inner diameter of the introducer sheath or outer diameter of the sds.The investigation was unable to determine conclusive cause for the reported difficulty to advance and remove.There is no indication of a product quality issue with respect to the design, manufacture.

• 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: 10151067
• MDR Text Key: 195918420
• Report Number: 2024168-2020-05002
• 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: 07/17/2020

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 Catalogue Number: UNK OMNILINK ELITE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/21/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1