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

Catalog Number 82086-01

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

Patient Problems Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Neurological Deficit/Dysfunction (1982); Weakness (2145); Numbness (2415)

Event Date 10/06/2014

Event Type  Injury  

Event Description

It was reported that during a procedure on (b)(6) 2014 to treat a lesion in the right carotid artery an emboshield nav 6 embolic protection system was advanced and deployed.A 4.0x30 mm rx trek dilatation catheter was advanced and pre-dilatation was performed.A xact 9tx40x136 carotid stent system was advanced and deployed without any issue.Post dilatation was performed with a 5x30 mm viatrac dilatation catheter.After post dilatation was performed the patient experienced some neurological events and transient symptoms including non-verbal and unable to move left side.The patient had left sided weakness, numbness in the left arm, hand and finger tips.The patient's blood pressure dropped and dopamine and neosynephrine were administered for treatment.The emboshield nav6 eps filter was successfully retrieved.One hour post procedure the patient's symptoms almost completely resolved.On (b)(6) 2014, the patient experienced mental status change and a fever which resolved.The physician felt the mental status change and fever were induced by some of the medications given (atropine, dopamine, and neosynephrine) computed tomography scans were performed and the results were normal.A magnetic resonance imaging (mri) was performed and the results indicated a small occipital stroke and the patient was medically managed and all symptoms resolved.The patient is doing great and was discharged to home on (b)(6) 2014.It is possible that the neurological events and other symptoms were related to the xact stent.No additional information was provided.

Manufacturer Narrative

(b)(4).Estimated age of the patient as the patient was reported to be in their (b)(6)'s.Concomitant products: embolic protection: emboshield nav 6; dilatation catheter: 5.0x30 mm viatrac.There was no reported device malfunction and the product was not returned.The reported patient effects of stroke, hypotension, neurological complications, and weakness are known observed and potential patient effects as listed in the xact carotid stent system instruction for use.Although a conclusive cause for the reported patient effects, and the relationship to the product, if any, could not be determined, there is no indication of a product quality deficiency with respect to manufacturing, design or labeling.

• 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: 4215471
• MDR Text Key: 21877132
• Report Number: 2024168-2014-07123
• 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: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82086-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2014
• 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
• Treatment: CONCOMITANT MEDICAL DEVICES
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 80 YR