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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 RSINT35015UX
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/17/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
The physician intended to use a resolute integrity 3.5 x 15mm drug-eluting stent.It was confirmed that the stent was inspected and seen to be normal when removed from original packaging.It is reported that, following many pre-dilations, the stent was noted to be deformed, after pushing, during attempted delivery in a heavily calcified cto vessel.
 
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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 Key6176509
Report Number9612164-2016-01303
Device Sequence Number16232834
Product Code NIQ
UDI-Device Identifier00643169037113
UDI-Public00643169037113
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
P110013
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 11/23/2016
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 Date06/28/2018
Device Catalogue NumberRSINT35015UX
Device Lot Number0008118934
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/23/2016
Initial Report FDA Received Date12/15/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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