MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDEAVOR SPRINT RX; CORONARY DRUG-ELUTING STENT

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

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

Journal article: coronary artery bypass surgery compared with percutaneous coronary intervention for proximal left anterior descending artery treatment in patients with acute coronary syndrome: analysis from the acuity trial authors: marco g.Mennuni, george d.Dangas, roxana mehran, yanai ben-gal, ke xu, philippe genereux, sorin j.Brener, frederick feit, a.Michael lincoff, e.Magnus ohman, martial hamon, gregg w.Stone journal: journal of invasive cardiology year: 2015 reference: pmid: 26121708 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 deaths was provided.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article titled "coronary intervention for proximal left anterior descending artery treatment in patients with acute coronary syndrome: analysis from the acuity trial" was submitted for review.The aim of the study was to compare the outcomes of acute coronary syndrome (acs) patients with proximal left anterior descending (plad) culprit lesions receiving percutaneous coronary intervention (pci) vs coronary artery bypass graft (cabg).The study endpoint included major adverse cardiac event (mace) which was defined as death from any cause, mi, or unplanned revascularization.The acuity trial was a prospective, open-label, randomized, multicenter trial with a sample which consisted of 13,819 moderate-risk and high-risk acs patients.A group of 6921 patients were included in the acuity angiographic sub-study.Of these patients, 4581 underwent revascularization: 3826 with pci and 755 with cabg.Among these, 842 patients presented with a plad culprit lesion.Revascularization was performed with pci in 562 patients and cabg in 280 patients.Patients were randomized to receive heparin with a glycoprotein (gp) iib/iiia inhibitor, bivalirudin plus a gp iib/iiia inhibitor, or bivalirudin alone.Coronary angiography was performed in all patients within 72 hours of randomization with subsequent triage to percutaneous, surgical, or medical management.Stent type was determined by operator discretion and resulted in approximately 85% des use in the pci population.Medtronic endeavour sprint stents were among the stents used.Before surgery, a 5-day clopidogrel wash-out was recommended.All patients received unfractionated heparin during cabg.After hospital discharge, aspirin was recommended indefinitely to all patients, while clopidogrel was recommended for at least 1 year in pci patients and at physician discretion in cabg patients.It was found that patients undergoing pci were more likely to have had previous cabg.Death, mi, mace, and stroke rates did not differ between groups at 1 year.Pci patients had lower bleeding rates and blood product transfusion at 30 days, but higher rates of unplanned revascularization at 1 year.

• Brand Name: ENDEAVOR SPRINT 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: 12727125
• MDR Text Key: 279249486
• Report Number: 9612164-2021-04141
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060033
• 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: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• 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: 10/15/2021
• 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): Required Intervention