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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 RSINT30015X
Device Problems Calcified (1077); Failure to Advance (2524); Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 07/11/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During the procedure, an attempt was made to use one resolute integrity drug eluting stent to treat a moderately tortuous and severely calcified lesion located in the mid left anterior descending artery, exhibiting 90% stenosis. There were no abnormalities reported in relation to anatomy. There was no damage noted to packaging. There were no issues noted when removing the device from the hoop. The device was inspected with no issues identified. Negative prep was performed with no issues noted. The lesion was pre-dilated. The device did not pass through a previously-deployed stent. Resistance was encountered when advancing the device. Excessive force was not used during delivery. It was reported that the stent failed to cross the lesion and stent deformation occurred during positioning. Patient status post-procedure is alive with no injury.
 
Manufacturer Narrative
The lesion was not adequately pre-treated. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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 Key7762093
MDR Text Key116872908
Report Number9612164-2018-01981
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P110013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/22/2019
Device Catalogue NumberRSINT30015X
Device Lot Number0008752112
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 Received11/13/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/22/2017
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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