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

Model Number 82087-01

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

Patient Problem Stroke/CVA (1770)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.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 stroke is listed in the xact instructions for use as a known potential adverse effect associated with carotid stents and embolic protection systems.In this case, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatment with medications was related to case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a carotid artery.A xact stent was implanted without issues and worked as intended.The patient was fine and sent to the post operation room.However, two hours later, the patient became unresponsive and started showing unspecified stroke symptoms.A computed tomography scan was performed and did not reveal any bleed.Therefore, tissue plasminogen activator (tpa) medication was provided and the patient condition improved.Per the physician, the xact stent did not cause or contribute to the stroke symptoms but rather the patients clinical condition of contralateral occlusion did.There was no adverse patient sequela and no clinically significant delay.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: 10979919
• MDR Text Key: 220640707
• Report Number: 2024168-2020-10350
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648010231
• UDI-Public: 08717648010231
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 82087-01
• Device Catalogue Number: 82087-01
• Device Lot Number: 0082062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2020
• 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
• Patient Age: 58 YR
• Patient Weight: 86