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 Myocardial Infarction (1969); Renal Failure (2041); Thrombosis/Thrombus (4440)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Journal article: (b)(6).Date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article titled (b)(6).Was submitted for review.The aim of this study was to assess the impact of chronic kidney disease (ckd) on clinical outcomes after percutaneous coronary intervention (pci) for unprotected left main distal bifurcation lesions (ulmd) in diabetes mellitus (dm) patients, comparing to those patients without ckd.The primary endpoint was target lesion failure (tlf).Tlf was defined as a composite of cardiac death, target lesion revascularization (tlr) for lm-lad and/or left circumflex coronary arteries, stent thrombosis (st) and myocardial infarction (mi).Death was considered as cardiac in origin unless obvious non-cardiac causes were identified.Tlr was defined as a repeat revascularization by pci or cabg of the target lesion.The stents used in the study included the medtronic endeavor rx, endeavor resolute and the resolute integrity drug eluting stents.1,832 consecutive patients who underwent pci for ulmd between january 2005 and december 2015 were identified.Of these, 512 dm patients who were not on hemodialysis were treated with des.The median follow-up period was 1870 days and 3 years clinical follow-up was available in 91.2% of the patients.Clinical outcomes reported from the study included tlf, cardiac death, tlr, mi, definite and probable stent thrombosis.It was also stated that two patients with severe ckd required hemodialysis during follow up periods.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• 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: 11737922
• MDR Text Key: 247908465
• Report Number: 9612164-2021-01705
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• 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: 04/15/2021
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 70 YR