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

Catalog Number 82091-01

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2017

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 not returned for analysis.Based on the reported information, the inaccurate delivery was due to case circumstances.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.The investigation determined the reported difficulty was due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a lesion located in the internal carotid artery with common carotid artery bifurcation.Mid-way through deployment of the xact 8t x 30 x 136 mm stent, the stent dropped to the common carotid artery due to patient's agitation.The stent was removed with the guide catheter.A new xact stent 40 mm was used to 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.

• Brand Name: XACT 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: 6777951
• MDR Text Key: 82607462
• Report Number: 2024168-2017-06531
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648010279
• UDI-Public: 08717648010279
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P040038
• 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
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 82091-01
• Device Lot Number: 6101061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• 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
• Patient Age: 74 YR
• Patient Weight: 65