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); Visual Disturbances (2140); Weakness (2145)

Event Date 08/08/2017

Event Type  Injury  

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 evaluation.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.Based on the case information and related record review, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The reported patient effects of stroke, neurologic symptoms, visual disturbances and weakness are listed in the xact instruction for use as known potential adverse effects.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that this was a procedure to treat a lesion in the internal carotid artery and common carotid artery.An emboshield nav 6 embolic protection system was advanced and deployed.A 4x30 mm viatrac dilatation catheter was used for pre-dilatation.A xact 8tx40x136 carotid stent system was advanced and deployed without any issue in the internal carotid artery.A 6-8 x 40 mm acculink stent system was advanced and deployed successfully in the common carotid artery; a 6x30x135 viatrac plus dilatation catheter was used for post dilatation.Upon completion of the procedure, after the emboshield nav 6 was removed; the patient experienced facial drooping, right side motor function loss, and incoherent speech.The patient had a stroke.Medication was used for treatment and the symptoms resolved.It is the physicians opinion that the stroke and symptoms are not related to the xact stent but are related to radiation the patient previously received for a neck tumor.The patient remains hospitalized, but in stable condition.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: 6811949
• MDR Text Key: 83298740
• Report Number: 2024168-2017-06856
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648175978
• UDI-Public: 08717648175978
• 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: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 82090-01
• Device Lot Number: 7041361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2017
• 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: 59 YR
• Patient Weight: 80