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

Catalog Number UNK XIENCE

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

Patient Problems Cardiac Arrest (1762); Myocardial Infarction (1969); Occlusion (1984); Thrombosis (2100)

Event Date 12/01/2013

Event Type  Injury  

Manufacturer Narrative

Event dates estimated.The additional patient death referenced will be filed under a separate medwatch report #.The additional device malfunctions referenced will be filed under a separate medwatch report #.The additional unk absorb referenced will be 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 part and lot numbers were not provided.The reported patient effects of myocardial infarction, cardiac arrest, thrombosis, and occlusion are listed in the xience everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects of myocardial infarction, cardiac arrest, occlusion 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 manufacture, design or labeling.The udi is unknown as the part and lot numbers were not provided.

Event Description

It was reported through a research article identifying xience that may be related to the following: patient death, myocardial infarction, thrombosis, cardiac arrest, revascularization, rehospitalization, malposition, and stents jailing or occluding vessels.Additionally, it was identified that absorb may be related to the following: patient death, myocardial infarction, thrombosis, dissection, revascularization, rehospitalization, and malposition.This article summarizes clinical outcomes of 1,845 patients that were treated with xience and absorb stents.Specific patient information is documented as unknown.Details are listed in the attached article, titled "comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent in routine pci: three-year clinical outcomes from the aida trial.".

Manufacturer Narrative

(b)(4).

• Brand Name: XIENCE DRUG ELUTING CORONARY STENT
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10005231
• MDR Text Key: 189234459
• Report Number: 2024168-2020-03944
• 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: 07/28/2020

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 XIENCE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2020
• Initial Date FDA Received: 04/28/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability