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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND ENDEAVOR RESOLUTE RX CORONARY DRUG-ELUTING STENT Back to Search Results
Device Problem Activation, Positioning or SeparationProblem (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.
 
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Brand NameENDEAVOR RESOLUTE RX
Type of DeviceCORONARY 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 Key12223970
MDR Text Key263393868
Report Number9612164-2021-02869
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P110013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
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 Received07/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/26/2021 Patient Sequence Number: 1
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