MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDEAVOR RX; CORONARY DRUG-ELUTING STENT

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

Patient Problems Myocardial Infarction (1969); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)

Event Date 09/04/2020

Event Type  Injury  

Manufacturer Narrative

Journal article: clinical outcomes and angiographic results of bailout stenting for guide catheter-induced iatrogenic coronary artery dissection journal: circulation journal year: 2020 ref: doi: 10.1253/circj.Cj-20-0123.Death was reported as a clinical outcome of this study, however there is no information to suggest the device has caused or contributed to a death.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article titled - clinical outcomes and angiographic results of bailout stenting for guide catheter-induced iatrogenic coronary artery dissection, impact of stent type was submitted for review.This is a retrospective single-center study which aimed to describe the initial and long-term outcomes of bailout stenting for iatrogenic coronary artery dissection caused by non medtronic catheters and the differences between drug eluting stents (des) and bare-metal stents (bms).The study sample consisted of 93 patients undergoing bailout stenting, using either des (52) or bms (41).One resolute integrity drug eluting stent and two endeavor rx drug eluting stents were among the des used in this study, along with other non-medtronic des.Clinical outcomes included cardiac death, target lesion revascularization (tlr), spontaneous myocardial infarction (mi), definite or probable stent thrombosis (st) and major adverse cardiac events (mace).Mace consisted of cardiac death, nonfatal spontaneous mi, and tlr.Tlr was defined as a repeated coronary procedure for restenosis or thrombosis of the target lesion within the stent or within 5 mm proximal or distal to the stent on cag.Coronary artery dissection post bailout stenting only occurred in patients who had a non-medtronic des inserted.Three of the four reported cardiac deaths are confirmed to have occurred in patients with non-medtronic des.

• Brand Name: ENDEAVOR RX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11973224
• MDR Text Key: 255343453
• Report Number: 9612164-2021-02246
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR