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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 RSINT22514X
Device Problem Device Expiration Issue
Event Date 05/01/2018
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Patient states that they had a resolute integrity rx drug eluting stent implanted and received a card after the procedure that had a sticker with an hour glass with a date approximately 33 months prior to the procedure date. The patient was concerned that the implanted stent had already expired when it was implanted. The patient does not know the exact name of the implanting facility or a contact number for the facility or the physician. The patient states that the stent was placed at a facility in (b)(6).

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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Brand NameRESOLUTE INTEGRITY RX
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway  
091708734
MDR Report Key7590464
Report Number9612164-2018-01404
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type CONSUMER,FOREIGN
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 10/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/12/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/18/2015
Device Catalogue NumberRSINT22514X
Device LOT Number0006912923
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/18/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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