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

Catalog Number 11009-29

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to abbott vascular for analysis.Return of the stent delivery system (sds), and inflation device may have further aided the analysis.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 similar incidents reported from this lot.Factors that may contribute to difficulty inflating the device or stent deployment issues may include, but are not limited to, manufacturing, bent/kinked shaft while inside the anatomy, contamination in the inflation lumen, patient anatomical morphology, patient disease state, inflation/deflation technique, contrast solution, inadequate connection to the inflation device, and/or accessory device support.To help ensure this difficulty is not related to a manufacturing issue, all stent delivery systems (sds) are visually inspected for damage in manufacturing.The investigation was unable to determine conclusive cause for the reported stent deployment issue as the device was not returned for analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the omnilink elite vascular balloon-expandable stent system was used during renal artery stenting.During attempted stent deployment at the lesion, the balloon was only minimally inflated, but failed to fully inflate.The stent was not deployed, remained secure on the balloon and was removed with the stent delivery system without issue.There was no reported adverse patient effect and no clinically significant delay in the procedure.Another device was used to stent the lesion.No additional information was provided.

• 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: 10953894
• MDR Text Key: 219885247
• Report Number: 2024168-2020-10195
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 11009-29
• Device Lot Number: 9101841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2019
• 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