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

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2020

Event Type  malfunction  

Manufacturer Narrative

Journal article: ticagrelor versus clopidogrel for prevention of subclinical stent thrombosis detected by optical coherence tomography in patients with drug eluting stent implantation¿a multicenter and randomized study authors: xiangqi wu, wei you, zhiming wu, qiang wu, jun jiang, hua yan, fei ye, shaoliang chen journal: platelets year: 2021 reference: doi: 10.1080/09537104.2020.1754381 please note that this device (endeavor resolute) is not marketed in the united states; however, it is similar to the united states marketed device (resolute integrity).This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.Average age, majority gender, average weight, date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article titled - ticagrelor versus clopidogrel for prevention of subclinical stent thrombosis detected by optical coherence tomography in patients with drug-eluting stent implantation¿a multicenter and randomized study - was submitted for review.This prospective, multicenter, randomized study was designed to analyze the benefits of ticagrelor over clopidogrel in reducing subclinical stent thrombosis (st) in patients with de novo coronary artery disease who underwent implantation of a second-generation drug-eluting stent (des).The primary end point was the occurrence of subclinical st detected by oct at 1-year follow-up.The secondary end points included percentage of uncovered stent struts per patient, maximal neointimal hyperplasia (nih) within the stent, and the stent struts malapposition and edge dissection.In total 352 patients with single de novo coronary stenosis were randomly assigned to either the clopidogrel group (aspirin plus clo pidogrel) or the ticagrelor group (aspirin plus ticagrelor) after des implantationfor 1 year.Patients were randomly divided into ticagrelor group or clopidogrel group in a 1:1 ratio.A maintenance dose of clopidogrel or ticagrelor was prescribed for 1 year, starting after the procedure.Aspirin was prescribed indefinitely for all patients for lifelong use.The percutaneous coronary intervention (pci) procedure was performed according to current standards.Pre-dilation wasat the primary operator's discretion and post dilation was done with a noncompliant nc balloon.The medtronic endeavor resolute coronary des was among the stents used during the procedures.Outpatient visits were scheduled at 1, 3, 6, 9, and 12 months after pci.Optical coherence tomography (oct) was obtained during the initial pci and at 1 year follow-up with a non-medtronic oct system.During 1 year follow up, there were not any differences in the incidence of bleeding (major and minor bleeding) and major adverse cardiac events (maces) (revascularization because of in-stent restenosis) between the two groups.The percentage of endothelial coverage, neointimal hyperplasia, malapposition, and edge dissection about stents were not different between the two groups.Incidences of dyspnea occurred in 2 patients in the ticagrelor group and resolved within two weeks.Mild chest tightness occurred more in the ticagrelor group than the clopidogrel group.The incidence of subclinical st in ticagrelor group was significantly low as compared to clopidogrel group at 1-year follow-up.

Manufacturer Narrative

Additional information: annex d code added 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.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 RESOLUTE RX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12223970
• MDR Text Key: 263393868
• Report Number: 9612164-2021-02869
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 68