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

Catalog Number 1010133-40

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the procedure was to treat a lesion in the internal carotid artery.During advancement, the 7.0 x 10 x 40 mm acculink had difficulties advancing and could not reach the lesion.Under x-ray, the acculink tip was noted to be interacting with the guide wire.After several attempts were made to advance the device it was removed from the patients anatomy with resistance noted due to interaction with the guide wire.The tip was found to be damaged.There was no adverse patient effect and no clinically significant delay in the procedure.A new 7.0 x 10 x 40 mm acculink was used to complete the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual, dimensional and functional inspections were performed on the returned device.The difficulty loading the guide wire and tip damage was confirmed.The difficulty to remove was not confirmed as it was based on case circumstances.Analysis of the returned device identified a portion of the device tip had been cut off and not returned.A review of the lot history record revealed no non-conformances issued to the reported lot that would have contributed to this event.A review of the complaint history no revealed no other incidents.An expanded review was conducted that identified an issue potentially related to raw material received by the manufacturer.Although the damage was confirmed, the issue appears to be isolated and not a systemic issue.The performance of these devices will continue to be monitored.

• 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: 5749062
• MDR Text Key: 48156375
• Report Number: 2024168-2016-04110
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 1010133-40
• Device Lot Number: 5080461
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• 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