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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 RSINT25018UX
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2016
Event Type  Malfunction  
Event Description

It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent to treat a moderately calcified and moderately tortuous proximal lad lesion exhibiting 80% stenosis. No damage noted to device packaging and no issues were noted when removing the devices from the hoop/tray. No issues noted removing the protective sheath. The device was inspected and negative prep performed with no issues noted. It was reported that the lesion was not pre-dilated. The device did not pass through a previously deployed stent. No resistance was encountered advancing the device and no excessive force used. During stent deployment the resolute integrity stent seemed to jump forward when the physician inflated the balloon to 16atm. A non-mdt guidewire was used and the stent was post dilated using a nc euphora to post dilate. No clinical sequelae reported.

 
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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 Key6188606
MDR Text Key62850807
Report Number9612164-2016-01336
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP110013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/05/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/20/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/10/2017
Device Catalogue NumberRSINT25018UX
Device LOT Number0007644289
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 Received12/05/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/11/2015
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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