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 Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Thrombus (2101); Stenosis (2263); Injury (2348)

Event Date 05/31/2019

Event Type  Injury  

Manufacturer Narrative

Journal title: long-term comparison of platinum chromium everolimus-eluting stent vs.Cobalt chromium zotarolimus-eluting stent ¿ 3-year outcomes from the host¿assure randomized clinical trial ¿ date of event= date of publication doi: 10.1253/circj.Cj-18-1303.If information is provided in the future, a supplemental report will be issued.

Event Description

The aim of this study was to compare the long-term outcome of platinum chromium-based everolimus-eluting stents (ptcr-ees) vs.Cobalt chromium-based zotarolimus-eluting stents (cocr-zes) in (b)(6).3755 patients were included in the study.Resolute integrity rx stents were implanted in 1252 of the population.Intensified and dual antiplatelet therapy was given as recommended in most patients.Patients implanted with the resolute integrity rx des were assessed 3 years post implantation.Clinical outcomes reported in the study population included death, myocardial infarction, tvr, restenosis, stent thrombosis, stroke and hemorrhage.No information was available about the cause of cardiac death.It was noted that the resolute integrity rx and non-medtronic dess had similar and excellent long-term outcomes in both efficacy and safety after pci in an all-comer east asian population.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9435065
• MDR Text Key: 176234326
• Report Number: 9612164-2019-05039
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2019

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: 11/23/2019
• Initial Date FDA Received: 12/08/2019
• 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: 61 YR