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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 RSINT27526UX
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/09/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
The physician intended to use a resolute integrity drug eluting stent to treat a lesion in the mid lad with 95% stenosis.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray.The device was inspected before use with no issues noted.Excessive force was not used during delivery.It is was reported that stent deformation occurred in-vivo during positioning.It was noted that a distal stent strut stuck out while still on the balloon.The physician completed the procedure and the patient is alive with no injury.
 
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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 Key7081967
Report Number9612164-2017-01714
Device Sequence Number11045400
Product Code NIQ
UDI-Device Identifier00643169037465
UDI-Public00643169037465
Combination Product (Y/N)N
Initial Reporter StateND
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 Physician
Type of Report Initial
Report Date (Section B) 12/05/2017
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 Date02/14/2019
Device Catalogue NumberRSINT27526UX
Device Lot Number0008490099
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/10/2017
Initial Report FDA Received Date12/05/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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