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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 RSINT40030UX
Medical Device Problem Code Difficult to Remove (1528)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/28/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
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.
 
Event or Problem Description
The physician intended to use a resolute integrity drug eluting stent.It was reported that the stent delivery system got stuck inside the pressure wire and the tip of the wire was not able to be removed from the rx port of the stent balloon.This happened when staff tried to remove the stent delivery system after stent deployment.No harm to the patient.
 
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Brand Name
RESOLUTE INTEGRITY RX
Common Device Name
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
MDR Report Key6525497
Report Number9612164-2017-00523
Device Sequence Number19149528
Product Code NIQ
UDI-Device Identifier00643169037243
UDI-Public00643169037243
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
P110013
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date09/21/2018
Device Catalogue NumberRSINT40030UX
Device Lot Number0008228989
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/28/2017
Initial Report FDA Received Date04/27/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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