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

Model Number	1804250-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Obstruction/Occlusion (2422); Embolism/Embolus (4438)
Date of Event	10/13/2022
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.A conclusive cause for the reported patient effect(s), 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; therefore, no product-related corrective action will be implemented in this case.The reported patient effect(s) of myocardial infarction, embolism, cerebrovascular accident and occlusion are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.
Event or Problem Description
Patient id; (b)(6).The procedure was to treat the mid left anterior descending (lad) coronary artery with bifurcation, mild calcification, mild tortuosity and no thrombus.A 6fr guide catheter was used and the lesion was confirmed with intravascular ultrasound (ivus), then the 3.5x18 mm xience skypoint stent was implanted without issue at 16 atmospheres (atm) and post dilatation was performed.In the 2nd diagonal coronary artery, a cutting balloon was used to modify the lesion, a semi-compliant balloon was used to pre-dilatation and the 2.5x23 mm xience skypoint stent was implanted without issue, with post-dilatation.Side-branch occlusion occurred due to the 2.5x23 mm xience skypoint stent in the 2nd diagonal artery and a myocardial infarction occurred; however, no stent thrombosis was noted.Another stent was used to bail out.When the event occurred, clopidogrel, aspirin and direct oral anticoagulant (doac) were prescribed.In post-procedure, modest elevation of creatine phosphokinase (cpk) and creatine kinase-mb (ck-mb) was observed, but ecg changes and chest symptoms were resolved later; therefore, the patient was discharged from the hospital on (b)(6) 2022.After discharge from the hospital, the patient returned to their primary doctor and on (b)(6) 2022 it was confirmed that there was a cerebral thromboembolism [ischemic stroke].At this time, aspirin was discontinued.

• 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: 15759910
• Report Number: 2024168-2022-11411
• Device Sequence Number: 6352647
• Product Code: NIQ
• UDI-Device Identifier: 08717648233098
• UDI-Public: 08717648233098
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2022

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: 05/17/2024
• Device Model Number: 1804250-23
• Device Catalogue Number: 1804250-23
• Device Lot Number: 1051141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• 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: 3.5X18 MM XIENCE SKYPOINT STENT.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 53 KG