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

Catalog Number UNK XIENCE

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

Patient Problems Intimal Dissection (1333); Thrombosis (2100); Prolapse (2475)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: date is estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Date of implant is estimated.The devices were not returned for analysis.A review of the lot history records and complaint histories could not be conducted because the part and lot numbers were not provided.The reported patient effects of intimal dissection, thrombosis and prolapse are listed in the xience everolimus eluting coronary stent system (eecss), electronic instructions for use (ifu) as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, 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 malposition of the stent referenced and in the attached article is filed under another mfr report number.Attachment: literature: early vascular responses to everolimus-eluting cobalt¿chromium stent in the culprit lesions of st-elevation myocardial infarction: results from a multicenter prospective optical coherence tomography study (mechanism-ami 2-week follow-up study).

Event Description

It was reported through a research article identifying xience family stents that may be related to the following: thrombosis, plaque prolapse, dissection and malposition of the stent.This article summarizes clinical outcomes of 52 patients that were treated with unspecified xience family stents.Specific patient information is documented as unknown.Details are listed in the attached article, titled "early vascular responses to everolimus eluting cobalt¿chromium stent in the culprit lesions of st elevation myocardial infarction: results from a multicenter prospective optical coherence tomography study (mechanism ami 2 week follow up study)".

• 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
• 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: 11174795
• MDR Text Key: 227005759
• Report Number: 2024168-2021-00466
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 64