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

Catalog Number 82086-01

Device Problems Inaccurate Delivery (2339); Physical Resistance (2578)

Patient Problem Vasoconstriction (2126)

Event Date 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

Internal file number - (b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.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 identified no other incidents from this lot.The investigation determined the reported difficulties and patient effect (vessel spasm) appear to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported the procedure was performed to treat a lesion with moderate calcification and mild tortuosity in the internal carotid artery.An attempt was made to direct stent with a 9 x 40 mm xact stent.The xact stent system was advanced, but could not cross the lesion due to the anatomy.The physician attempted multiple times pushing the device, but was unsuccessful and the vessel went into spasm.The xact was removed from the anatomy without resistance, and a 4.0 x 20 mm viatrac balloon catheter was advanced for pre-dilatation.Then, the xact was re-advanced but still could not cross the lesion due to the anatomy and was withdrawn from the anatomy a second time.Once again, dilatation was performed using a 5.0 x 20 mm viatrac balloon catheter.The xact was advanced a third time; however, vessel spasm occurred again.The patient was given medication for the vessel spasm.The xact was advanced to the target lesion, but during deployment the stent jumped distally.Therefore, a 9 x 30 mm xact was advanced without issue and implanted proximally with a 5 mm overlap of the 9 x 40 mm xact stent to successfully cover the remaining part of the lesion.Post dilatation was performed with good results.There was no adverse patient effect and no 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: 6977628
• MDR Text Key: 90983407
• Report Number: 2024168-2017-08466
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648010224
• UDI-Public: 08717648010224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040038
• 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
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 82086-01
• Device Lot Number: 5080361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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