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

Model Number	82098-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); High Blood Pressure/ Hypertension (1908); Dizziness (2194); Stenosis (2263)
Date of Event	06/25/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2024168-2023-01622
• Device Sequence Number: 17750655
• Product Code: NIM
• UDI-Device Identifier: 08717648010347
• UDI-Public: 08717648010347
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2023

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 Model Number: 82098-01
• Device Catalogue Number: 82098-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male