MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1120275-38

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

Patient Problems Angina (1710); Thrombosis/Thrombus (4440)

Event Date 03/12/2024

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a lesion in the left anterior descending (lad) and proximal left circumflex (plcx) with 90% stenosis, mild calcification and mild tortuosity.The patient's left ventricular ejection fraction (lvef) was 48%.The plcx was treated with 2.5x15mm xience alpine stent at 16 atmospheres (atms) and post dilated with 2.5x12mm nc trek balloon.The lad was treated with 2.75x38 xience alpine stent at 16 atms and post dilated with 2.75x20mm nc trek balloon at 18 atms.Post dilatation was performed per standard procedure.Timi 3 flow was achieved.There was no adverse patient effect and there was no clinically significant delay in the procedure.However, on (b)(6) 2024, the patient came back with chest pain and both vessels where the stents were implanted confirmed blockage on coronary artery angiography (cag).Electrocardiogram (ecg) and troponin test was performed for the chest pain.Occlusion was confirmed to be thrombosis.Patient was referred for coronary artery bypass grafting (cabg) and unknown when it will be performed.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.Lot history record (lhr) and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The reported patient effects of thrombosis and angina are listed in the xience alpine everolimus eluting coronary stent system (eifu), electronic instructions for use (eifu),) as a known patient effect 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.The additional xience alpine device(s) referenced in b5 is/are filed under separate medwatch report number(s).

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT 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: 19139626
• MDR Text Key: 340560977
• Report Number: 2024168-2024-04851
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648205644
• UDI-Public: (01)08717648205644(17)260110(10)3011641
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/18/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 1120275-38
• Device Lot Number: 3011641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/11/2023
• 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
• Patient Outcome(s): Hospitalization