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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
Catalog Number INT40012UX
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Myocardial Infarction (1969)
Date of Event 02/03/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
During the index procedure, a resolute integrity drug eluting stent was implanted in the rca.Approx.35 months post index procedure, two integrity bare metal stents were implanted in the cx.One day post implant of the integrity bare metal stents, troponin elevation was reported.Cec adjudicated the event as non-q wave mi of the non-target vessel.
 
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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 Key7888479
Report Number9612164-2018-02430
Device Sequence Number1861784
Product Code MAF
UDI-Device Identifier00613994798626
UDI-Public00613994798626
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P030009
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) 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date11/02/2018
Device Catalogue NumberINT40012UX
Device Lot Number0008360602
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/23/2018
Initial Report FDA Received Date09/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
Patient Age78 YR
Patient Weight75
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