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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Myocardial Infarction (1969); Sudden Cardiac Death (2510)
Event Date 05/23/2018
Event Type  Death  
Manufacturer Narrative
Title: two-year clinical outcome of all-comers treated with three highly dissimilar contemporary coronary drug-eluting stents in the randomised bio-resort trial authors: marlies m. Kok, md; paolo zocca, md; rosaly a. Buiten, md; peter w. Danse, md, phd; carl e. Schotborgh, md; martijn scholte, md; marc hartmann, md, phd; martin g. Stoel, md, phd; k. Gert van houwelingen, md; gerard c. M. Linssen, md, phd; carine j. M. Doggen, phd; clemens von birgelen, md, phd journal: eurointervention year:2018 issue: 14 ref: doi: 10. 4244/eij-d-18-00336. Age/date of birth
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average age. Sex
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majority gender. Date of event
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date of publication. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Resolute integrity drug-eluting stent was implanted in 1,173 patients in the study population. Patients were on dapt for 12-months and followed a stringent dapt discontinuation policy after one year. The primary composite endpoint of target vessel failure (tvf) assessed device efficacy and patient safety and consisted of cardiac death, target vessel-related myocardial infarction (mi), or clinically indicated target vessel revascularisation. Secondary endpoints included: target lesion revascularisation (tlr), target lesion failure (tlf, a composite of cardiac death, any mi not clearly attributable to a non-target vessel, or clinically driven tlr), major adverse cardiac events (mace, a composite of all-cause death, any mi, or emergent coronary bypass surgery, or repeat clinically indicated tlr), the most global patient-oriented composite endpoint (poce, a composite of all-cause death, any mi, or any repeat coronary revascularisation), and definite-or-probable stent thrombosis. During follow-up, clinical events reported in patients treated with resolute integrity zes were death, myocardial infarction, revascularization and stent thrombosis.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameRESOLUTE INTEGRITY RX
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key7684713
MDR Text Key113868299
Report Number9612164-2018-01717
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
P110013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received08/08/2018
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: 07/13/2018 Patient Sequence Number: 1
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