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

Model Number	1804225-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	03/08/2022
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.The reported patient effects of death/expired and myocardial infarction are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling of the device.The xience skypoint des 2.25 x 12 referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a right posterior atrio-ventricular and right posterior descending lesions on 5/20/2021.Pre-dilatation was performed with semi-compliant balloon.A 2.25x18mm xience skypoint was deployed at 10 atmospheres without post dilatation.Then a 2.25x12mm xience skypoint was deployed at 16 atmospheres with post diliatation.No issue was noted during the procedure.On (b)(6) 2021 and (b)(6) 2022, the patient came to the hospital but no issue was noted on the patient's condition during those visits.On (b)(6) 2022, the patient died.Relation between the incident and the study is not determined.Per the physicians clinical decision the cause of death was due to acute myocardial infarction.It is unknown if an autopsy was performed.No angiography was performed.Prescribed anti-platelet drugs (clopidogrel, aspirin) were stopped being applied by the time the patient was released from hospital after percutaneous coronary interventional procedure.No additional information.

• 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: 14160929
• Report Number: 2024168-2022-04243
• Device Sequence Number: 5609431
• Product Code: NIQ
• UDI-Device Identifier: 08717648233005
• UDI-Public: 08717648233005
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2022

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: 09/10/2023
• Device Model Number: 1804225-18
• Device Catalogue Number: 1804225-18
• Device Lot Number: 0090341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2020
• 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
• Outcome Attributed to Adverse Event: Disability; Death
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 78 KG