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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 RSINT25026X
Device Problems Inflation Problem (1310); Activation, Positioning or SeparationProblem (2906); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/13/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a procedure an attempt was made to use one resolute integrity rx coronary drug eluting stent to treat lesion. It was reported that the stent did not expand. The procedure was successfully completed using a resolute onyx stent along with a solarice and nc solarice balloon and a launcher guide catheter. The patient was doing well and no patient injury was reported.
 
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Brand NameRESOLUTE INTEGRITY RX
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key11542647
MDR Text Key242670745
Report Number9612164-2021-01079
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodePL
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 05/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRSINT25026X
Device Lot Number0010502662
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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