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

Catalog Number	82090-01
Health Effect - Clinical Codes	Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982); Visual Disturbances (2140); Weakness (2145)
Date of Event	08/08/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: CAROTID STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6811949
• Report Number: 2024168-2017-06856
• Device Sequence Number: 16391788
• Product Code: NIM
• UDI-Device Identifier: 08717648175978
• UDI-Public: 08717648175978
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/22/2017

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: 03/31/2020
• Device Catalogue Number: 82090-01
• Device Lot Number: 7041361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 08/22/2017
• 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; Required Intervention; Disability
• Patient Age: 59 YR
• Patient Weight: 80