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	Non specific EKG/ECG Changes (1817); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Obstruction/Occlusion (2422); Embolism/Embolus (4438)
Date of Event	05/17/2022
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 occlusion, myocardial infarction and embolism 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; however, the subsequent treatment appears 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 of the device.
Event or Problem Description
Clinical research: (b)(6) study patient id; (b)(6).It was reported that on (b)(6) 2022, the patient presented for percutaneous coronary intervention (pci) in the distal left circumflex (lcx) artery and left atrioventricular (lav) artery.After lesion preparation with a semi-compliant balloon, the lcx was the first to be stented.First a 3x23mm xience skypoint was deployed at 14 atmospheres in the lav with standard post-dilatation performed afterwards.Per the physician, distal embolism of the lav was noted and associated with post-dilatation after the stent deployment at the time of the initial pci.Then a 4x23mm xience skypoint was deployed at 20 atmospheres in the lcx with standard post-dilatation performed afterwards.There were no complications when pci was performed.Myocardial infarction (mi) occurred due to side branch occlusion of the lav at the time of the pci but was later identified post pci on the same day of the procedure.The site of onset of mi is in the lav lesion, and st-elevation was confirmed.Ck level elevation was also confirmed.Continuous infusion of nicorandil medication was started.Patient was discharged on (b)(6) 2022 (2 days) after pci.No additional information was provided.Per the physician there was no relation between the incident and the study/the xience devices.

• 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: 14610608
• Report Number: 2024168-2022-06032
• Device Sequence Number: 19947316
• Product Code: NIQ
• UDI-Device Identifier: 08717648233258
• UDI-Public: 08717648233258
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2022

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: 10/25/2024
• Device Model Number: 1804300-23
• Device Catalogue Number: 1804300-23
• Device Lot Number: 110184A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• 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: 7FR GUIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 84 KG