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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
Catalog Number UNK-CV-GWY-INT-DES
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Sudden Cardiac Death (2510)
Event Date 03/04/2018
Event Type  Death  
Manufacturer Narrative
Literature reference: doi: 10. 1097/mca. 0000000000000620. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Resolute integrity drug eluting stent devices were used to treat lesions in the lad, lcx and rca with an average stenosis of 85%. It is reported that post-procedure, side-branch occlusion occurred in two patients. There was also a trend towards greater side-branch diameter stenosis in the group treated with drug eluting stents. Cardiac death caused by sudden death during sleep occurred in one patient three months after the index procedure. Tlr and tvr are also reported to have occurred.
 
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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 Key7849667
MDR Text Key119317449
Report Number9612164-2018-02303
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 company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK-CV-GWY-INT-DES
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 Received08/15/2018
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: 09/06/2018 Patient Sequence Number: 1
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