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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 UNK-CV-GWY-INT-DES
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2017
Event Type  malfunction  
Manufacturer Narrative
Additional information: the nc sprinter device was being used to post-dilate a new non-medtronic stent. 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.
 
Event Description
The physician intended to use an nc sprinter balloon catheter to treat a lesion in the ostium of the left main coronary artery. There were no abnormalities in relation to anatomy. The lesion was pre-dilated. The device passed through a previously-deployed stent. The device was being used to post-dilate a newly deployed medtronic stent (model unknown). It is reported that the balloon got stuck on the stent after the stent was deployed. The balloon was fully deflated prior to attempting to remove the device. The stent was then removed from the patient using the balloon catheter. It was reported that no force was used to remove the balloon. No further intervention was required to remove the balloon or the stent from the patient. No damage was reported to the stent upon its removal. No damage was done to the artery walls. No patient injury was reported. The balloon did not get stuck on the previously deployed stent during advancement before reaching the target stent. No further stenting was required.
 
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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 Key7192846
MDR Text Key106869820
Report Number9612164-2018-00074
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
Report Date 04/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK-CV-GWY-INT-DES
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 Received03/27/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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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