MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDEAVOR 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); Insufficient Information (4580)

Event Date 02/27/2023

Event Type  Injury  

Event Description

A journal article was submitted for review titled; five-year outcomes of biodegradable versus second-generation durable polymer drug-eluting stents used in complex percutaneous coronary intervention.The aim of this study was to demonstrate the effect of procedural complexity in patients undergoing percutaneous coronary intervention (pci), and to evaluate the safety and efficacy of biodegradable polymer drug-eluting stents (bp-des), compared with those of second-generation durable polymer drug-eluting stents (dp-des), in patients with and without complex percutaneous coronary intervention (cpci) during a 5-year follow-up.A total of 7712 patients who received either bp-des (n = 1590) or dpdes (n = 6122) in 2013 were enrolled.The study population was stratified into two categories based on the pci complexity.Cpci was defined as having at least one of the following features: unprotected left main lesion, =2 lesions treated, =2 stents implanted, total stent length >40 mm, moderately-to-severely calcified lesion, chronic total occlusion (cto), or bifurcated target lesion.There were no medtronic devices used in the bp-des group.Medtronic endeavor and endeavor resolute des were among the des used in the dp-des group.The pci strategy and stent type were at the discretion of the operating surgeon.Clinical presentation included non-st elevation-acute coronary syndrome (nste-acs), st segment elevation myocardial infarction (stemi), and stable angina.All patients were evaluated by clinic visits or telephone calls at 1, 3, 6, and 12 months and annually thereafter.Overall, the 5-year follow-up was completed for 91.5% patients.The primary endpoint was the composite of major adverse cardiac events (mace), which was defined as the occurrence of all-cause death, recurrent myocardial infarction (mi), and total coronary revascularization during follow-up.The secondary endpoint was total cor onary revascularization including target lesion revascularization (tlr), target vessel revascularization (tvr), and non-tvr.Bleeding academic research consortium criteria, and bleeding types 2, 3, and 5 were included in the analysis.Among the 7712 included patients, 4882 (63.3%) underwent cpci.In the cpci group bp-des were used in 21.5% (1051) of patients, while dp-des were used in 78.5% (3831).And in the non-cpci groups, bp-des were used in 19.0% (539) of patients, while dp-des were used in 81.0% (2291).There was a significantly increased incidence of 2 and 5 year mace and total revascularization in cpci patients compared with non-cpci patients.The incidence of mace and total coronary revascularization were not significantly different between the bp-des and dp-des groups at the 2-year follow-up, regardless of pci complexity.Similar results were reported in non-cpci patients at the 5-year follow-up.However, in patients who underwent cpci, those who received bp-des were associated with a higher 5-year crude risk of mace and total coronary revascularization, compared with those who received dp-des.Incidents of bleeding and stroke were reported from all groups at 2 and 5 years.Please note that the endeavor resolute device is not marketed in the united states; however, it is similar to the united states marketed device resolute integrity rx coronary drug eluting stent.

Manufacturer Narrative

Title: five-year outcomes of biodegradable versus second-generation durable polymer drug-eluting stents used in complex percutaneous coronary intervention year: 2023 reference: doi: 10.1097/cm9.0000000000002450 a2: average age a3: majority gender b3: date of publication medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: annex d code.Correction: 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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDEAVOR 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18490713
• MDR Text Key: 332603069
• Report Number: 9612164-2024-00199
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P060033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• 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?: No
• Date Manufacturer Received: 02/01/2024
• 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
• Patient Age: 58 YR
• Patient Sex: Male