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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 RSINT30030X
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/16/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
An attempt was made to use a resolute integrity rx coronary drug eluting stent to treat a non-tortuous and mildly calcified lesion. The device was inspected with no issues noted. Negative prep was not performed. The lesion was pre-dilated. The device did not pass through a previously-deployed stent. Resistance was encountered but no excessive force used. It was reported that stent deformation occurred due to the use of the device in a tight lesion. The stent was replaced by another manufacturer's device to complete the procedure. The physician assessed that the event was due to use of device in difficult lesion. No patient injury was reported.
 
Manufacturer Narrative
The stent was positioned on the balloon between the marker bands as per specifications. Deformation was evident to the 11th distal stent wraps with struts raised. No deformation was evident to the distal tip. The inner lumen patency could not be verified with a 0. 015 inch mandrel most likely due to hardened blood in the guidewire lumen. No other damage evident to the remainder of the device. 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 Key8188756
MDR Text Key131177980
Report Number9612164-2018-03752
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeTU
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 03/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/18/2021
Device Catalogue NumberRSINT30030X
Device Lot Number0009191525
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/19/2018
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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