MAUDE Adverse Event Report: AV-TEMECULA-CT RX ACCULINK CAROTID STENT SYSTEM

Catalog Number 1011344-40

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2019

Event Type  malfunction  

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 additional relevant information.

Event Description

It was reported that the procedure was performed to treat a heavily tortuous carotid artery.Endarterectomy had been performed 10 days prior to the procedure to open the vessel.An unspecified embolic protection system was advanced, and the filter was deployed.A 7-10x40mm acculink self-expanding stent system (sess) was then advanced with anatomical resistance.Resistance was also felt with the anatomy when the sess was pulled back to position the stent in the lesion.The stent was attempted to be deployed; however, the lever on the handle was difficult to move and the stent completely failed to deploy.The sess was removed from the patient anatomy and was inspected.It was confirmed there were no other issues noted with the sess.Deployment was then tested, and the stent was only able to deploy halfway.A 7-10x30mm acculink sess was used to successfully complete the procedure.There were no adverse patient effects, and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).The device was not returned for 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 of the reported lot revealed no other incidents.The investigation was unable to determine a cause for the reported difficulties.It may be possible that the shaft was kinked or entrapped in the heavily tortuous anatomy preventing the shaft lumens from moving freely and preventing the thumbslide from being able to retract; however, this could not be confirmed.The resistance with the anatomy was likely due to anatomical challenges.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: RX ACCULINK CAROTID STENT SYSTEM
• Type of Device: CAROTID STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8672921
• MDR Text Key: 147186397
• Report Number: 2024168-2019-04472
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 1011344-40
• Device Lot Number: 9021961
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 52