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

Model Number	1804300-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/02/2023
Type of Reportable Event	Death
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.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.The reported patient effects of death and hemorrhage are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effects of coronary stenting procedures.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 patient was stable prior to the procedure and was scheduled for an outpatient procedure due to angina.The 3.0x23 mm xience skypoint stent was implanted in the lad with mild-moderate calcification and mild tortuosity and the 2.75x38 mm xience skypoint was implanted in the rca with mild tortuosity.The stents were implanted without issue.When the patient was in recovery, they coded and were brought back to the cath lab.However, the patient continued to code in the lab and cpr was performed for 30-45 minutes and then the patient expired.No angiography was able to be done to check for thrombus.The cause of death was coagulopathy.It was not determined if the xience skypoint stents caused or contributed to the death.No additional information was provided.

• 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: 16620370
• Report Number: 2024168-2023-03064
• Device Sequence Number: 17641234
• Product Code: NIQ
• UDI-Device Identifier: 08717648233258
• UDI-Public: 08717648233258
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• 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): 03/27/2023

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: 11/20/2024
• Device Model Number: 1804300-23
• Device Catalogue Number: 1804300-23
• Device Lot Number: 2112441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• 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: 2.75X38 MM XIENCE SKYPOINT.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown