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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 RSINT40026X
Device Problem Device Expiration Issue
Event Date 01/11/2018
Event Type  Malfunction  
Event Description

A resolute integrity drug eluting stent was intended to be used to treat a moderately tortuous and calcified lesion with 70-80% stenosis in the proximal rca. There was no damage noted to the device packaging. There were no issues noted when removing the device from the hoop. The device was inspected with no issues. Negative prep was performed. The lesion was pre-dilated. Resistance was encountered when advancing the device. Excessive force was not used during delivery. It is reported that the device failed to cross the lesion and was therefore replaced with another manufacturers device. No patient injury is reported. The physician has reported that the positioning difficulties event was due to the use of the device in a difficult lesion morphology/anatomy and is not device related. The device was used 120 days beyond its expiry date.

 
Manufacturer Narrative

Product analysis: no packaging was returned with the device except hoop/tray, therefore confirmation of expiry date could not be performed. Protective sheath and stylette were returned loaded in device. The stent was positioned on the balloon between the marker bands as per specifications. No deformation was evident to stent wraps. No deformation was evident to the distal tip. If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

Additional information: no patient injury or medical/surgical intervention was required as a result of the expired product being used in the patient. The case was completed by another manufacturer¿s device. The patient¿s status post procedure was reported to be fine. 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 Key7224114
Report Number9612164-2018-00155
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/29/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/13/2017
Device Catalogue NumberRSINT40026X
Device LOT Number0007723958
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/17/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/14/2015
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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