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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND INTEGRITY RX; STENT, CORONARY
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MEDTRONIC IRELAND INTEGRITY RX; STENT, CORONARY Back to Search Results
Model Number INT30030UX
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/09/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that an integrity bare metal stent bent while attempting to cross a lesion in the mid rca.
 
Additional Manufacturer Narrative
Additional information: some resistance was experienced during advancement but no excessive force was used.The procedure was completed with another stent.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
INTEGRITY RX
Common Device Name
STENT, CORONARY
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
MDR Report Key7395076
Report Number9612164-2018-00632
Device Sequence Number1216309
Product Code MAF
UDI-Device Identifier00613994798534
UDI-Public00613994798534
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P030009
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,Followup
Report Date (Section B) 06/15/2018
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 Date09/06/2018
Device Model NumberINT30030UX
Device Catalogue NumberINT30030UX
Device Lot Number0008207714
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/09/2018
Supplement Date Received by Manufacturer03/09/2018
Initial Report FDA Received Date04/04/2018
Supplement Report FDA Received Date06/15/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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