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

Catalog Number 1120250-33

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

Patient Problems Angina (1710); Non specific EKG/ECG Changes (1817); Obstruction/Occlusion (2422)

Event Date 02/29/2024

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a lesion in the left anterior descending (lad) artery with moderate calcification and mild tortuosity.After pre-dilatation with a 2.5x15mm balloon, the 2.5x33mm xience alpine stent was implanted.Post-dilatation was performed with 2.75x12mm and 3.5x10mm balloons.Then, a 2.25x28mm xience alpine stent was implanted in the lcx.The patient experienced chest pain with changes in st levels.Angiography noted that the lad diagonal had become completely occluded.Therefore, a 2x15mm balloon and a 1.5x8mm balloon were used to treat the occluded diagonal.There was no adverse patient sequela.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.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.The reported patient effects of angina and occlusion are listed in the xience alpine everolimus eluting coronary stent system (eifu), electronic instructions for use as a known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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: 18925492
• MDR Text Key: 337922105
• Report Number: 2024168-2024-03453
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1120250-33
• Device Lot Number: 3022341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• 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
• Treatment: 2.25X28MM XIENCE ALPINE STENT
• Patient Outcome(s): Required Intervention