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

Model Number	82088-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762)
Date of Event	05/18/2020
Type of Reportable Event	Serious Injury
Additional 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 effects of bradycardia/arrhythmia are listed in the xact instructions for use as known potential patients effects associated with carotid stents and embolic protection systems.Based on the case information, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The additional therapy/non-surgical treatment and treatment with medication was related to case circumstances.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 to treat a heavily calcified lesion in the heavily tortuous right common carotid artery.An emboshield nav6 embolic protection system (eps) was used and a viatrac 14 dilatation catheter was used for post dilatation.After the 9.0x9.0x30 mm xact stent was implanted, the patient experienced a drop in pulse and asystole.The patient was stabilized with cpr and medication and continued to be stable.The physician reported that this was a very difficult case due to the highly calcified area.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
• MDR Report Key: 10140841
• Report Number: 2024168-2020-04898
• Device Sequence Number: 2027677
• Product Code: NIM
• UDI-Device Identifier: 08717648010248
• UDI-Public: 08717648010248
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: P040038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2020

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: 06/30/2022
• Device Model Number: 82088-01
• Device Catalogue Number: 82088-01
• Device Lot Number: 9070861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 73 YR