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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND ENDEAVOR 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 01/01/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article was submitted for review titled: clinical implications of poststent optical coherence tomographic findings: severe malapposition and cardiac events. The aim of the study was to evaluate the impact of poststent optical coherence tomography (oct) findings including severe malapposition on long-term clinical outcomes. A total of 1,290 patients with 1,348 lesions who underwent oct immediately post stenting were eligible for this study and were enrol led. Lesions treated included the left main, left anterior descending artery, left circumflex artery, right coronary artery and ramus intermedius. Lesions had a mean stenosis of 66%. Patients received drug-eluting stents (des) including sirolimus-eluting stents, p aclitaxel-eluting stents, zotarolimus eluting stents, everolimus eluting stents or biolimus a9-eluting stents. Medtronic endeavour rx stents and resolute integrity stents were the zotarolimus eluting stents used during this study. Each des was implanted according to current standard techniques and pre-dilation, post-stent dilation, application of mechanical support or concomitant medication, were performed at the discretion of the operator. Post-stent oct findings included stent edge dissection, stent malaposition, malapposed struts, tissue protrusion/prolapse, thrombus and stent under expansion. Follow up oct was performed at 3, 6, or 12 months after the initial angioplasty. Cardiac deaths, definite, probable and possible stent thromboses, stent occlusion, target vessel-related mi and target lesion revascularization (tlr).
 
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Brand NameENDEAVOR 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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key14141447
MDR Text Key289505902
Report Number9612164-2022-01506
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
P060033
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 07/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2022
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
Date Manufacturer Received06/15/2022
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: 04/19/2022 Patient Sequence Number: 1
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