MAUDE Adverse Event Report: ABBOTT VASCULAR XACT CAROTID STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number 82098-01

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

Patient Problems Headache (1880); High Blood Pressure/ Hypertension (1908); Dizziness (2194); Stenosis (2263)

Event Date 06/25/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record of the reported lot could not be conducted because the lot number was not provided.The reported patient effects of stenosis, headache and hypertension are listed in the xact carotid stent system information for prescribers as adverse events potentially associated with carotid stents and embolic protection systems.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.The treatments appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The date of event is estimated as (b)(6) 2022.The date of implant is estimated as (b)(6) 2022.

Event Description

It was reporter that the 10x30 mm xact carotid stent was implanted one year ago in the left internal carotid with heavy calcification.Approximately 6 months after the stent was implanted, the patient began experiencing headaches, dizziness and hypertension and in-stent restenosis was confirmed.The patient was attempted to be treated medically; however, the medication did not seem to alleviate any of the symptoms.A ct scan was performed and it was decided to place another stent on (b)(6) 2023 to treat the in stent restenosis.There were no reported adverse patient sequela.No additional information was provided.

• Brand Name: XACT CAROTID STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16398570
• MDR Text Key: 309782421
• Report Number: 2024168-2023-01622
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648010347
• UDI-Public: 08717648010347
• 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: Physician
• Type of Report: Initial
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 82098-01
• Device Catalogue Number: 82098-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male