MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY RX; STENT, CORONARY, DRUG-ELUTING

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

Patient Problems Angina (1710); Arrhythmia (1721); Myocardial Infarction (1969); Thrombosis (2100); Heart Failure (2206); Injury (2348); Vascular Dissection (3160)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

Journal title: comparison between the outcomes of using biodegradable-polymer drug-eluting stents and those using durable-polymer drug-eluting stents in acute coronary syndrome patients undergoing percutaneous coronary intervention.Date of event = date of publication.Doi.Org/10.3889/oamjms.2019.345.If information is provided in the future, a supplemental report will be issued.

Event Description

205 patients were enrolled in a study.The aim of the study was to compare the biodegradable-polymer des with durable polymer des when it comes to reducing the incidence of non-st elevation acute coronary syndrome (nsteacs) associated with adverse events.A selection of patients received resolute integrity rx drug eluting stents as part of the study.Patients were noted to have coronary lesions narrowed by 60%.Adverse events / procedural complications reported included acute in-stent thrombosis, arrhythmia, no-reflow phenomenon and coronary dissection.Revascularization (tlr), mi, lv dysfunction and mortality were reported in hospital.A selection of patients that received durable-polymer des (including resolute integrity) consented to have repeat coronary angiography within 1 year.Angina pains were reported with a small number of patients requiring tlr and experiencing mi.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9289407
• MDR Text Key: 165378230
• Report Number: 9612164-2019-04677
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2019
• 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: 57 YR