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

Catalog Number 1011343-40

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The additional emboshield device referenced is being filed under a separate medwatch report.

Event Description

It was reported that the vessel was to treat a bifurcated internal and common carotid artery.The nav6 and the 80x40mm acculink carotid stent were prepped per the instructions for use.The nav6 was positioned at the lesion first.Then as the acculink was advanced over the barewire (nav6), it became stuck.The physician was unable to advance further.When attempting to remove the acculink resistance was met with the barewire.After some force and manipulation, the acculink was able to be removed.Consequently, this caused the nav6 filter to pull into the vessel, while still being on the bare wire.Once the acculink was outside of the anatomy, the retrieval catheter was used to retrieve the filter.An xact stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Correction- device status changed from returning to not returned.The device was not returned to abbott vascular 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 identified no similar incidents reported from this lot.It should be noted that the rx acculink carotid stent system electronic instruction for use (ifu) states: if resistance is met during delivery system introduction, the system should be withdrawn and another system used.Although it was noted the physician used some force in the attempts to remove the device, this was due to the device interacting with other devices, therefore the force applied during removal of the device seemed to be a reasonable clinical response to the difficulties.The investigation determined the reported difficulty to position and remove the device from the guide wire appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 8375803
• MDR Text Key: 137395124
• Report Number: 2024168-2019-01532
• 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: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 1011343-40
• Device Lot Number: 8022861
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EMBOLIC PROTECTION: EMBOSHIELD NAV6
• Patient Age: 56 YR
• Patient Weight: 72