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 Myocardial Infarction (1969); Thrombus (2101)

Event Date 03/17/2020

Event Type  Injury  

Manufacturer Narrative

Title: coronary calcification and long-term outcomes according to drug-eluting stent generation authors: paul guedeney, bimmer e.Claessen, roxana mehran, et.Al.Journal: jacc: cardiovascular intervention issue: 12 ref: doi.Org/10.1016/j.Jcin.2020.03.053.Age=average age.Sex= majority gender.Ethnicity= majority race.Date of event=date of publication patient death(s) were also included in the results of the journal article, however no causal link suggesting that the medtronic device(s) 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

An article titled "coronary calcification and long-term outcomes according to drug-eluting stent generation" was submitted.The aim of the study was to evaluate the long-term impact of coronary artery calcification (cac) on outcomes after percutaneous coronary intervention and the respective performance of first- and second-generation drug-eluting stents (des).This study was a large patient-level meta-analysis of 18 randomized trials comprising 19,833 patients treated with des.The patients were divided into two groups based on the type of stents they were treated with: first generation des and second generation des.The endeavor rx and resolute integrity rx were among the stents used to treat patients in the second generation des group.Second generation des were used in 11,960 patients.Clinical outcomes were assessed at 5 year follow up.Clinical outcomes included all-cause and cardiac death, myocardial infarction, any revascularization, target lesion revascularization (tlr), target lesion failure and probable or definite stent thrombosis.

• Brand Name: ENDEAVOR RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10331194
• MDR Text Key: 202337841
• Report Number: 9612164-2020-02748
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• 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: 07/15/2020
• 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: 63 YR