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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND RESOLUTE INTEGRITY 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
Title: clinical implications of poststent optical coherence tomographic findings severe malposition and cardiac events authors: byung gyu kim, md, mateusz kachel, jung-sun kim, giulio guagliumi et al. Journal: jacc: cardiovascular imaging issue: 1 ref: https://doi. Org/10. 1016/j. Jcmg. 2021. 03. 008. Average age, majority gender, date of publication 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 death(s) was provided. 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 malposition and cardiac events. The aim of the study was to evaluate the impact of poststent optical coherence tomography (oct) findings including severe malposition 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, paclitaxel-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 malposition, malposed 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 NameRESOLUTE INTEGRITY 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 Key14141491
MDR Text Key289515888
Report Number9612164-2022-01507
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeKS
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
Report Date 04/19/2022
1 Device was Involved in the Event
0 Patients were 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 Received04/12/2022
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

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