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

Catalog Number	82086-01
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	10/11/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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for pre-dilatation.Then, the xact was re-advanced but still could not cross the lesion due to the anatomy and was withdrawn from the anatomy a second time.Once again, dilatation was performed using a 5.0 x 20 mm viatrac balloon catheter.The xact was advanced a third time; however,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
• Common Device Name: CAROTID STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6977628
• Report Number: 2024168-2017-08466
• Device Sequence Number: 13615447
• Product Code: NIM
• UDI-Device Identifier: 08717648010224
• UDI-Public: 08717648010224
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 82086-01
• Device Lot Number: 5080361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1