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

Catalog Number UNK RX XPEDITION

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

Patient Problems Death (1802); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 09/09/2020

Event Type  Death  

Manufacturer Narrative

Date of death: estimated date of death.Date of event: estimated date of event.The unique device identifier (udi) is unknown because the part number and lot number were not provided.Date of implant: estimated date of implant.The device was not returned for evaluation.A review of the lot history record of the reported lot could not be conducted because the part and lot number were not provided.A conclusive cause for the reported death and the relationship to the product, if any, cannot be determined.The reported patient effect of death, is listed in the xience v everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional adverse patient effects referenced will be filed under a separate medwatch report number.Attached article, titled "ultrathin-strut biodegradable polymer versus durable polymer drug-eluting stents: a meta-analysis.".

Event Description

It was reported through a research article identifying that xience stents may be related to the following: death, myocardial infarction, stent-thrombosis, target lesion failure, rehospitalization and revascularization.This article summarizes clinical outcomes of 2886 patients that were treated with xience stents.Specific patient information is documented as unknown.Details are listed in the attached article, titled "ultrathin-strut biodegradable polymer versus durable polymer drug-eluting stents: a meta-analysis.".

Manufacturer Narrative

The reported patient effect of death is listed in the xience xpedition, xience xpedition sv, and xience xpedition ll everolimus eluting coronary stent system instructions for use as a known patient effect of coronary procedures.The other xience prime and xience alpine mentioned in b5 will be referenced in separate medwatch numbers.D1, d4: part number changed from unk xience to unk rx xpedition.

Event Description

It was reported through a research article identifying that xience stents may be related to the following: death, myocardial infarction, stent-thrombosis, target lesion failure, rehospitalization and revascularization.This article summarizes clinical outcomes of (b)(4) patients that were treated with xience stents.Specific patient information is documented as unknown.Details are listed in article, titled "ultrathin-strut biodegradable polymer versus durable polymer drug-eluting stents: a meta-analysis.".B5 correction: the xience stents involved in the clinical trials of the listed article are xience xpedition, xience prime, and xience alpine.

• Brand Name: RX XIENCE XPEDITION
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11322004
• MDR Text Key: 231616035
• Report Number: 2024168-2021-01141
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX XPEDITION
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 63 YR