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

Catalog Number UNK XIENCE

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

Date of event and implant: estimated date.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The absorb referenced is being filed under a separate medwatch report number.This copy of copyrighted material was made and delivered to the government under a license from the rights holder or its authorized agent.No further reproduction is permitted.

Event Description

It was reported through a research article identifying absorb and xience that may be related to the following; myocardial infarction, device thrombosis, re-hospitalization and final minimal lumen diameter of the scaffold and stent.Additionally, a general statement was made regarding dissatisfaction with absorb.Specific patient information is documented as unknown.Details are listed in the attached article, titled "outcomes of optimised implantation technique with bioresorbable scaffolds: a pooled analysis of absorb-iv and compare-absorb trials".

Manufacturer Narrative

D4.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The investigation determined a conclusive cause for the reported difficult or delayed activation cannot be determined.The reported patient effects of thrombosis and myocardial infarction are listed in the xience v everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported thrombosis and myocardial infarction, 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.

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.Attachment: [cn-026598 article.Pdf].

• Brand Name: XIENCE 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: 9855857
• MDR Text Key: 187029961
• Report Number: 2024168-2020-02643
• 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,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE
• 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; Disability