MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number	1804250-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Cardiac Arrest (1762); Obstruction/Occlusion (2422)
Date of Event	07/08/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
The stent remains implanted and will not be returning for analysis.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat lesions in the left anterior descending (lad) artery and the right coronary artery (rca).Two xience skypoint stents were implanted, without issue in the lad (2.25x38mm, 2.5x28mm), and one stent implanted in the rca (3.5x33mm).The patient was sent to recovery but approximately an hour after the procedure, the patient experienced chest pain and went into cardiac arrest.Cardiopulmonary resuscitation was started and the patient was taken back to the cath lab.At that point, it was noted that the 2.5x28mm xience skypoint stent, implanted in the mid to distal lad was occluded with a timi flow grade of zero.Ballooning was done to try to open the vessel, but everything was stopped due to the low chance of recovery and the patient¿s age and the patient expired.No additional information was provided.
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 cardiac arrest, obstruction/occlusion, death / expired, and angina are listed in the xience skypoint instruction for use (ifu) as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and their relationship to the product, if any, cannot be determined; however, the subsequent treatments appear 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.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15135703
• Report Number: 2024168-2022-08370
• Device Sequence Number: 20164418
• Product Code: NIQ
• UDI-Device Identifier: 08717648233104
• UDI-Public: 08717648233104
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• 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,Followup
• Report Date (Section B): 08/31/2022

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: 01/23/2024
• Device Model Number: 1804250-28
• Device Catalogue Number: 1804250-28
• Device Lot Number: 2011541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• 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: 2.25X38MM XIENCE SKYPOINT
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown