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

Catalog Number UNK RX PRIME

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

Patient Problems Intimal Dissection (1333); Ischemia (1942); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 01/13/2016

Event Type  Injury  

Manufacturer Narrative

Date of event will be estimated as (b)(6) 2016 due to one year follow up from stent implantation.The udi is unknown because the part number and lot number were not provided.Date of implant will be estimated as (b)(6) 2015 estimated five years from publication date.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.The reported patient effects of ischemia, intimal dissection, myocardial infarction and thrombosis are listed in the xience prime everolimus eluting coronary stent system instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported ischemia, intimal dissection, myocardial infarction and thrombosis and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The patient deaths referenced are being filed under a separate medwatch report.

Event Description

It was reported through a research article identifying xience prime may be related to the following: patient death, myocardial infarction, ischemia, thrombosis, dissection, revascularization, treatment with medication, and rehospitalization.This article summarizes clinical outcomes of 1400 patients that were treated with xience prime stents.Specific patient information is documented as unknown.Details are listed in the attached article, titled "effect of intravascular ultrasound¿ guided drug-eluting stent implantation 5-year follow-up of the ivus-xpl randomized trial.".

• Brand Name: XIENCE PRIME 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: 10489102
• MDR Text Key: 205541880
• Report Number: 2024168-2020-07358
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: KS
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/03/2020

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: UNK RX PRIME
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 63 YR
• Patient Weight: 25