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

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

Patient Problems Arrhythmia (1721); Atrial Fibrillation (1729); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Thrombosis/Thrombus (4440)

Event Date 11/04/2021

Event Type  Injury  

Manufacturer Narrative

Journal article: fractional flow reserve¿guided pci as compared with coronary bypass surgery authors: william f fearon, frederik m zimmermann, bernard de bruyne, zsolt piroth, albert h m van straten, laszlo szekely, giedrius davidavicius, gintaras kalinauskas, samer mansour, rajesh kharbanda journal: the new england journal of medicine year: 2022 reference: doi: 10.1056/nejmoa2112299.Patient deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic devices used in the patient cohort may have caused or contributed to the death(s) was provided.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted titled: fractional flow reserve¿guided pci as compared with coronary bypass surgery.The study was a multicenter, international, non-inferiority trial, where patients with three-vessel coronary artery disease were randomly assigned to undergo coronary-artery bypass grafting (cabg) or fractional flow reserve (ffr) guided percutaneous coronary intervention (pci) with current-generation zotarolimus-eluting stents.A total of 1500 patients were randomized with 757 randomly assigned to undergo pci and 743 to undergo cabg.The lesions treated included vessels with chronic total occlusion and bifurcation lesions.Patients treated with pci received either resolute integrity or resolute onyx drug eluting stents.At 1 year follow up the following end points were noted in the pci group: death from any cause, myocardial infarction, stroke, repeat revascularization, barc type 3¿5 bleeding, acute kidney injury, atrial fibrillation or clinically significant arrhythmia, definite stent thrombosis and rehospitalization within 30 days.

Manufacturer Narrative

Journal article: fractional flow reserve¿guided pci as compared with coronary bypass surgery authors: william f fearon, frederik m zimmermann, bernard de bruyne, zsolt piroth, albert h m van straten, laszlo szekely, giedrius davidavicius, gintaras kalinauskas, samer mansour, rajesh kharbanda journal: the new england journal of medicine year: 2022 reference: doi: 10.1056/nejmoa2112299.Patient deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic devices used in the patient cohort may have caused or contributed to the death(s) was provided.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted titled: fractional flow reserve¿guided pci as compared with coronary bypass surgery.The study was a multicenter, international, non-inferiority trial, where patients with three-vessel coronary artery disease were randomly assigned to undergo coronary-artery bypass grafting (cabg) or fractional flow reserve (ffr) guided percutaneous coronary intervention (pci) with current-generation zotarolimus-eluting stents.A total of 1500 patients were randomized with 757 randomly assigned to undergo pci and 743 to undergo cabg.The lesions treated included vessels with chronic total occlusion and bifurcation lesions.Patients treated with pci received either resolute integrity or resolute onyx drug eluting stents.At 1 year follow up the following end points were noted in the pci group: death from any cause, myocardial infarction, stroke, repeat revascularization, barc type 3¿5 bleeding, acute kidney injury, atrial fibrillation or clinically significant arrhythmia, definite stent thrombosis and rehospitalization within 30 days.

• Brand Name: RESOLUTE INTEGRITY 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: 13496779
• MDR Text Key: 285328739
• Report Number: 9612164-2022-00536
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• 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: 01/18/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: White