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

Model Number 1804300-15

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Atrial Fibrillation (1729); Non specific EKG/ECG Changes (1817); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Thrombosis/Thrombus (4440)

Event Date 01/11/2023

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a de novo lesion in the proximal left anterior descending (plad) artery with mild calcification, and mild tortuosity.On (b)(6) 2023, the 3.0x15mm xience skypoint stent delivery system was implanted after a 7french (fr) guide catheter was inserted and pre-dilated with a semi-compliant balloon.Post-dilatation was performed.Additionally, the kissing balloon technique was performed in the plad and first diagonal artery.The procedure was completed.There were no issues during the procedure until discharged.Atrial fibrillation (af) was observed on echocardiogram (ecg) on (b)(6) 2023.On (b)(6) 2023, the patient complained of chest pain and the patient was transported by ambulance to the hospital.The patient was administered drug but chest pain persisted.Ecg was performed and af and complete right bundle branch block (crbbb) were noted so the patient was administered sunrythm.Additionally a direct currect defibrillator was used on the patient.Coronary angiogram (cag) was performed and then percutaneous coronary intervention (pci) was performed on the same day.Stent thrombosis in plad was suspected on cag and myocardial infarction was diagnosed due to elevated troponin-t and creatine kinase (ck) and ck-mb (creatine kinase-mb).Revascularization in the pci was completed with thromboaspiration plus balloon angioplasty.Clopidogrel, aspirin and direct oral anticoagulants (doac) had been prescribed prior to pci.At the time of discharge, aspirin was stopped and clopidogrel and doac were continued according to the protocol of this study.After revascularization, clopidogrel was replaced with prasugrel and aspirin was re-prescribed.There was no adverse patient sequela and there was no clinically significant delay in the procedure.No additional information was provided.

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 thrombosis, myocardial infarction, angina, and atrial arrythmia/fibrillation 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 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
• Type of Device: 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: 16372906
• MDR Text Key: 309502442
• Report Number: 2024168-2023-01480
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233234
• UDI-Public: 08717648233234
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2023
• Device Model Number: 1804300-15
• Device Catalogue Number: 1804300-15
• Device Lot Number: 0071741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 7FRENCH GUIDE CATHETER
• Patient Outcome(s): Required Intervention; Disability; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 54 KG