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

Catalog Number 82090-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982); Thrombosis (2100); Transient Ischemic Attack (2109); Weakness (2145)

Event Date 11/10/2014

Event Type  Injury  

Event Description

It was reported that the patient presented with dizziness, slurred speech, and was diagnosed with a transient ischemic attack (tia).On (b)(6) 2014, the 8.0mmx40mmx136cm xact stent was successfully deployed to treat a lesion in the left internal carotid artery.There were no reported device or procedure issues and the procedure was completed successfully.Later the same day while in recovery, the patient experienced slurred speech and slight left side weakness.The patient was diagnosed with a tia, which resolved without treatment within 45 minutes.A computed tomography (ct) scan was performed and no abnormality was noted.On (b)(6) 2014, the patient again experienced slurred speech and slight left side weakness, and was transferred to another hospital.While at the other hospital, the patient experienced a stroke, which was treated with unspecified medication.On (b)(6) 2014, angiogram revealed thrombosis of the deployed xact stent, which was treated the same day with deployment of an unspecified stent.The thrombosis was resolved and the patient was discharged from the hospital; however, the patient was transferred to a rehabilitation facility due to the stroke.There was no additional information provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.There was no reported device malfunction and the product was not returned.The lot history record (lhr) for this product could not be reviewed because the product was not returned for evaluation and the lot number was not reported.The reported patient effects of neurological deficit/dysfunction, weakness, transient ischemic attack (tia), cerebrovascular accident (cva), and thrombosis are known potential patient effects as listed in the xact carotid stent system instructions for use (ifu).Based on the information reviewed, there is no evidence to indicate the presence of a product deficiency.

• 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 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4351426
• MDR Text Key: 5222677
• Report Number: 2024168-2014-08366
• Device Sequence Number: 1
• Product Code: NIM
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82090-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 78 YR
• Patient Weight: 64