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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 RSINT25012X
Device Problems Device Expiration Issue; Difficult To Position
Event Date 11/19/2016
Event Type  Malfunction  
Event Description

It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent to treat a calcified and tortuous lesion in the mid lcx. It was reported that the lesion was dilated several times but the device failed to cross the target lesion. The device was used approximately 13 days post its use by date.

 
Manufacturer Narrative

The device was inspected prior to use with no issues noted. The product is sold on consignment. The account have a signed consignment agreement. Patient is stable. Procedure was completed with a resolute onyx drug-eluting stent. Event date updated. Event occurred prior to expiration date. Product was used before expiry date.

 
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 Key6188439
Report Number9612164-2016-01334
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/05/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/20/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/22/2016
Device Catalogue NumberRSINT25012X
Device LOT Number0007377593
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/23/2014
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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