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

Catalog Number UNK RX ALPINE

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

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Thrombosis (2100); Transient Ischemic Attack (2109); Stenosis (2263)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

Event estimated dates.The device was not returned for evaluation as the stent remains in patient.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.A conclusive cause for the reported cerebrovascular accident, stenosis, thrombosis, myocardial infarction, transient ischemic attack, and the relationship to the product, if any, cannot be determined.The reported patient effects of cerebrovascular accident, stenosis, thrombosis and myocardial infarction are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.The udi is listed as unknown because the part and lot #s were not provided.The additional patient effect (death) is being filed under a separate medwatch report number.The other two xience devices are being filed under separate medwatch report numbers.Literature attachment, titled, "everolimus-eluting biodegradable polymer versus everolimus-eluting durable polymer stent for coronary revascularization in routine clinical practice".

Event Description

It was reported through a research article identifying xience prime, xience xpedition, and xience alpine that may be related to death and serious injury.Specific patient information is documented as unknown.Details are listed in the attached article, titled everolimus-eluting biodegradable polymer versus everolimus-eluting durable polymer stent for coronary revascularization in routine clinical practice.

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• Brand Name: RX ALPINE
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9891534
• MDR Text Key: 188551047
• Report Number: 2024168-2020-03050
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX ALPINE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 69 YR