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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
Lot Number UNKNOWN
Device Problems Fracture; Activation, Positioning or SeparationProblem
Event Date 03/08/2018
Event Type  Malfunction  
Manufacturer Narrative

In-stent restenosis assessed with frequency domain optical coherence tomography shows smooth coronary arterial healing process in se cond-generation drug-eluting stents. Doi: https://doi. Org/10. 11622/smedj. 2018038. Age or date of birth= average age. Sex= majority gender. Date of event= date of publication. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Resolute integrity was one of four second generation stents implanted in 1,269 lesions from january 2011 to december 2014 in this retrospective study comparing the morphological characteristics of in stent restenosis (isr) between first and second generation des using frequency domain optical coherence tomography (oct). Follow-up coronary angiography (cag)was performed at 6¿9 months after pci and the second cag at 18¿24 months after pci. All patients had been taking aspirin with clopidogrel or prasugrel for at least one year. It was reported that of 51 second-generation des patients, 44 patients with second generation des isr were evaluated using frequency domain oct. The incidence of isr among patients for whom second-generation dess were implanted was significantly lower than that for first-generation des. Stent fracture or stent recoil with or without calcified nodules was reported in nine patients which were also considered to be the cause of isr in these nine patients.

 
Manufacturer Narrative

Additional information confirmed that there was no patients in the fracture or recoil group that had resolute integrity implanted. 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 Key9122727
Report Number9612164-2019-04103
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/25/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device LOT NumberUNKNOWN
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 Received10/18/2019
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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