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

Model Number	82091-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Paresis (1998); Thrombosis/Thrombus (4440)
Date of Event	05/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of vessel thrombosis is listed in the xact carotid stent system information for prescribers as an adverse event 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.However, the treatment 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.
Event or Problem Description
It was reported that the procedure was performed to treat the right internal carotid artery due to vision loss that the patient was experiencing on the left side, indicating an issue in the right artery with 99% stenosis, none calcification and none tortuosity.An emboshield nav6 embolic protection system (eps) was advanced and the first xact stent (lot 2121461) was implanted by direct stenting in the right internal carotid artery (ica) without issue.The emboshield nav6 was removed.At this time it was noted that the patient had lost movement in the foot and leg on the right side as well as a loss of speech.A clot had formed in the left ica/external carotid artery.An emboshield nav6 (lot 3031661) was attempted to be advanced but could not pass so balloon dilatation was performed with a viatrac balloon and then the emboshield nav6 was able to be advanced to the desired location.Then an xact stent was placed in the left ica and post dilated with the viatrac balloon.Four mg of tissue plasminogen activator (tpa) was administered.Flow to the brain was restored.The stents are patent.There was no diagnosis of stroke or transient ischemic attack.The patient remained hospitalized in the intensive care unit and three days later it was reported that the patient had improved with normal speech, regained right side movement and able to follow commands.The patient will be sent to rehabilitation for recovery.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: 17144298
• Report Number: 2024168-2023-06372
• Device Sequence Number: 5421863
• Product Code: NIM
• UDI-Device Identifier: 08717648010279
• UDI-Public: 08717648010279
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 06/16/2023

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 Expiration Date: 11/30/2025
• Device Model Number: 82091-01
• Device Catalogue Number: 82091-01
• Device Lot Number: 2121461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VIATRAC BALLOON
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 77 KG