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 Thrombosis (2100); Vascular Dissection (3160)

Event Date 11/15/2012

Event Type  malfunction  

Manufacturer Narrative

Dates estimated the adverse patient effects referenced in will be filed under a separate medwatch report #.The additional device referenced is being filed under a separate medwatch report #.The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The udi is unknown as the part and lot numbers were not provided.Article title: comparison of the vessel healing process after everolimus-eluting stent and bare metal stent implantations in patients with st-elevation myocardial infarctionna.

Event Description

It was reported through a research article identifying xience alpine and multilink vision that may be related to the following: patient thrombosis, dissection, malapposition, revascularization, and rehospitalization.This article summarizes clinical outcomes of 42 patients that were treated with xience alpine stents and 21 patients that were treated with multilink vision stents.Specific patient information is documented as unknown.Details are listed in the attached article, titled "comparison of the vessel healing process after everolimus-eluting stent and bare metal stent implantations in patients with st-elevation myocardial infarction.".

Manufacturer Narrative

B3/d6: dates estimated.B5: the adverse patient effects referenced in b5 will be filed under a separate medwatch report #.B5: the additional device referenced in b5 is being filed under a separate medwatch report #.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot and part number were not provided.A conclusive cause for the reported patient-device incompatibility could not be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The udi is unknown as the part and lot numbers were not provided.Article title: comparison of the vessel healing process after everolimus-eluting stent and bare metal stent implantations in patients with st-elevation myocardial infarctionna.

• 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
• MDR Report Key: 11252222
• MDR Text Key: 230233501
• Report Number: 2024168-2021-00722
• 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: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX ALPINE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR