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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 RSINT27526X
Device Problem Inflation Problem (1310)
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 proximal lad lesion. No damage noted to device packaging and no issues were noted when removing the devices from the hoop/tray. The device was inspected with no issues noted. It was reported that the lesion was not pre-dilated. During the procedure it was reported that the device did not pass through a previously deployed stent. No resistance was encountered or excessive force used. It was reported that the physician attempted to inflate the device at nominal pressure (9atms) but the device would not inflate at all. The inflation device was check and confirmed to be working after inflating another balloon. After removal, the physician attempted to inflate the stent on the table and it would not inflate. No patient injury reported. The physician successfully completed the procedure using another resolute integrity stent.

 
Manufacturer Narrative

There were a number of kinks visible along the hypotube. The stent was correctly positioned on the delivery system balloon with no evidence of attempted expansion. The balloon pillow and shoulder folds were intact. Negative prep was performed with no issues noted. The balloon was inflated to nominal pressure (9 atms) with no issues noted and maintained pressure. The support mandrel was removed to with no leaks detected on the inner distal shaft. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
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 Key6188677
MDR Text Key62851096
Report Number9612164-2016-01337
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberP110013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/17/2017
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 Date04/12/2018
Device Catalogue NumberRSINT27526X
Device LOT Number0008011372
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/11/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/12/2016
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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