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

Catalog Number 82096-01

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

Patient Problems Neurological Deficit/Dysfunction (1982); Stenosis (2263)

Event Date 04/09/2015

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2015 an xact stent was implanted in the right common to the internal carotid artery without issue.There was no adverse patient effect and no clinically significant delay during the index procedure.On (b)(6) 2015, the patient was re-admitted to the hospital due to global confusion and the xact stent that was implanted was found to have not been the right size for the target lesion and had restenosed.Additional angioplasty was required for treatment.No further treatment is required.The patient was in great condition and discharged to home on (b)(6) 2015.No additional information was provided.

Manufacturer Narrative

(b)(4).Estimated weight.There was no reported device malfunction and the product was not returned.The reported patient effects of neurological complications and restenosis are known observed and potential patient effects as listed in the xact carotid stent system instruction for use.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.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: 4721142
• MDR Text Key: 5661191
• Report Number: 2024168-2015-02245
• 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: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 82096-01
• Device Lot Number: 4111861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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
• Patient Age: 63 YR
• Patient Weight: 91