MAUDE Adverse Event Report: AV-TEMECULA-CT OMNILINK ELITE PERIPHERAL STENT SYSTEM

Catalog Number 1012623-59

Device Problems Material Separation (1562); Unstable (1667); Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat an unknown lesion.The omni elite vascular balloon-expandable 7.0 mm/59 mm stent system was advanced, but the stent came off the delivery balloon in the guiding catheter.Another same device was used to successfully complete the procedure.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Device codes: 2339 not labeled 1667 not labeled.Internal file number - (b)(4).Device code 1104 removed.The investigation determined the reported difficulties appear to be related to operational circumstances of the procedure.A review of the lot history record (elhr) for the reported lot revealed no associated nonconforming material records (ncmr).A query of the complaint handling database for the reported lot revealed no other incident reported for failure to advance or stent dislodgement.Based on the review of similar incidents there is no indication of a lot specific product quality issue.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial medwatch report, the following information was received: the lesion was located in an 80% stenosed, severely calcified, common iliac artery.Resistance was noted during advancement of the omni elite delivery system and during advancement, the stent started to dislodge, so the stent was deployed, but was not in the lesion.The final patient outcome was good.No additional information was provided.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Type of Device: PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8176875
• MDR Text Key: 131184603
• Report Number: 2024168-2018-09842
• 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,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 1012623-59
• Device Lot Number: 8050841
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other