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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY RX CORONARY DRUG-ELUTING STENT

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MEDTRONIC IRELAND RESOLUTE INTEGRITY RX CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number RSINT27522X
Device Problems Burst Container or Vessel (1074); Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Patient Problems Unspecified Tissue Injury (4559); Insufficient Information (4580)
Event Date 08/13/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
An attempt was made to use a resolute integrity coronary drug eluting stent to treat a mildly calcified, moderately tortuous lesion, with 80% of stenosis in the left anterior descending (lad) artery. There was no damage noted to the device packaging. There were no issues noted when removing the device from the protective hoop. The lesion was not pre-dilated. The device did not pass through a previously-deployed stent. It was reported that a balloon rupture occurred. It was noted that inflation difficulties occurred under 4 atm of pressure. It was also reported that the device was slow to deflate at the lesion site and difficulties to remove the device were encountered following the stent deployment. An intervention was required to release the stent from the balloon. No patient injury was reported.
 
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Brand NameRESOLUTE INTEGRITY RX
Type of DeviceCORONARY DRUG-ELUTING STENT
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 Key12342554
MDR Text Key267272686
Report Number9612164-2021-03208
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P110013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRSINT27522X
Device Catalogue NumberRSINT27522X
Device Lot Number0010482574
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/10/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/06/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/19/2021 Patient Sequence Number: 1
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