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

Catalog Number UNK-CV-GWY-INT-DES

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

Patient Problems Myocardial Infarction (1969); Thrombus (2101)

Event Date 05/11/2019

Event Type  Injury  

Manufacturer Narrative

Clinical and angiographic outcomes of bioabsorbable vs.Permanent polymer drug-eluting stents in sweden: a report from the swedish coronary angioplasty registry (scaar) sergio buccheri, stefan james, daniel lindholm, ole frobert, goran k.Olivecrona, jonas persson, kristiina hambraeus, nils witt, david erlinge, oskar angeras, bo lagerqvist and giovanna sarno european heart journal (2019) 40, 2607-2615 doi:10.1093/eurheart/ehz244.Age average age.Sex: majority gender.Date of event: date of publication 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

This study investigated the comparative outcomes of bioabsorbable polymer des (bp-des) and permanent polymer des (pp-des) implanted across swedish cardiac catheterization laboratories from october 2011 to june 2016.Resolute integrity and resolute onyx devices along with non-medtronic drug eluting stents implanted among the 79,106 pp-des implanted in 47 ,455 individual patients.Lesions treated included the left main, right coronary, left anterior descending, left circumflex arteries, arterial graft and vein graft were treated with chronic total occlusion in 2547 patients, bifurcation in 8486 patients.2,149 patients exhibited restenotic lesions.Rotational atherectomy was used in 404 patients, direct stenting in 12 ,482 patients, and post-dilation performed in 18,087 patients.Complete revascularization was carried out in 31,843 cases.Follow-up analysis carried out across both pp-des and bp-des groups for up to 2 years reported restenosis, stent thrombosis, myocardial infarction and all cause mortality.The study was unable to classify different causes of death.

• 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: 9284160
• MDR Text Key: 179274136
• Report Number: 9612164-2019-04661
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 11/06/2019

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
• Device Catalogue Number: UNK-CV-GWY-INT-DES
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/06/2019
• 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 Outcome(s): Life Threatening; Required Intervention
• Patient Age: 67 YR