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

Catalog Number	82086-01
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	08/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical devices: vessel closure: starclose, embolic protection: emboshield nav6.The device was not returned for evaluation.The reported patient effect of stroke is listed in the xact instructions for use as known potential adverse effect.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the case information and related record review, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the left internal carotid artery.An emboshield nav6 was used for protection and a 9tx40x136 cm xact stent was deployed successfully in the lesion.The procedure went as planned without any complications or any noted device issues; however, post-procedure, when talking with the patient, it was observed that he had difficulty talking and a hard time moving his right arm.The patient was sent to a different hospital and a computed tomography (ct) scan was performed which did not reveal anything out of the ordinary.An angiogram was performed which revealed a distal m2 infarct.It cannot be determined at what point during the procedure the infarct took place.No treatment was performed and as of (b)(6) 2017, the patient is reported to be doing well and recovering in hospital.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: 6838134
• Report Number: 2024168-2017-07222
• Device Sequence Number: 1566744
• Product Code: NIM
• UDI-Device Identifier: 08717648010224
• UDI-Public: 08717648010224
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 82086-01
• Device Lot Number: 6050261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Disability
• Patient Age: 73 YR
• Patient Weight: 92