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

Catalog Number 1011343-40

Device Problems Improper or Incorrect Procedure or Method (2017); Physical Resistance (2578); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2016

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 stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The emboshield nav6 referenced is being filed under a separate medwatch mfr number.

Event Description

It was reported the procedure was to treat a lesion in the internal carotid artery.After placement of the emboshield nav 6 embolic protection system, the 6-8 x 40 mm acculink was advanced in the vessel, but could not cross the lesion due to the patient anatomy.The device was withdrawn from the patient and set aside.A 7 x 30 mm acculink was unpackaged and prepped, but a gap was noted at the tip; therefore, it was conservatively decided not to use the device as it was a very difficult vessel.The 6-8 x 40 mm acculink was re-inserted using the buddy wire and was able to cross the lesion.The acculink stent was deployed over the buddy wire and trapped the emboshield nav6 filter wire against the vessel wall.The 6-8 acculink stent was on the buddy wire, but should have been on the barewire.There were no adverse, neurological patient effects during the procedure.Unable to remove the filter, the patient was sent to surgery for cut down of the vessel to pull the filter out successfully.The patient is doing well.There was no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.The emboshield nav 6 embolic protection system (eps) instruction for use (ifu): instructs, perform the required interventions over the barewire filter delivery wire.In this case, failing to follow the ifu caused the epd to become jailed resulting in surgery to remove the filter.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other similar incidents.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determine that the difficulties appear to be due to user error and there is no indication the issue was caused by, or related to the design, manufacture or labeling of the device.The surgical intervention was due to operational context.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5814291
• MDR Text Key: 50307185
• Report Number: 2024168-2016-04827
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 1011343-40
• Device Lot Number: 5031761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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