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

Catalog Number UNK RX ALPINE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Intimal Dissection (1333); Thrombosis (2100)

Event Date 03/14/2016

Event Type  Injury  

Manufacturer Narrative

Estimated date of event.Estimated date of implant.The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot number were not provided.The reported patient effects of thrombosis and dissection are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as known patient effects of coronary procedures.The investigation determined a conclusive cause for the reported patient-device incompatibility-wall apposition cannot be determined.Additionally, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the 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.Article, titled "early vascular responses after everolimus-eluting stent implantation assessed by serial observations of intracoronary optical coherence tomography.".

Event Description

It was reported through a research presentation identifying xience alpine stents that may be related to malaposition which led to dissection, thrombus, revascularization and rehospitalization.This article summarizes clinical outcomes of 45 patients that were treated with xience alpine stents.Specific patient information is documented as unknown.Details are listed in the article, titled "early vascular responses after everolimus-eluting stent implantation assessed by serial observations of intracoronary optical coherence tomography.".

• 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: 11186237
• MDR Text Key: 227570323
• Report Number: 2024168-2021-00513
• Device Sequence Number: 1
• Product Code: NIQ
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX ALPINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention