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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
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem Injury (2348)
Event Date 07/09/2019
Event Type  Injury  
Manufacturer Narrative
Journal title: incidence, retrieval methods, and outcomes of intravascular ultrasound catheter stuck within an implanted stent: systematic literature review doi. Org/10. 1016/j. Jjcc. 2019. 07. 005. Date of event: date of publication. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The aim of this study was to investigate the incidence, retrieval methods, and outcomes of ivus catheter stuck within implanted stents. 705 patients underwent stent implantation in this study. 10 patients suffered from an ivus catheter stuck in an implanted stent. Lesions were noted to be very tortuous and severely calcified. A 3. 00x12 mm resolute integrity rx coronary drug eluting stent was implanted in one patient in the left anterior descending (lad) artery. Aspirin (100 mg/day) and clopidogrel (75 mg/day) were administered in all patients prior to pci. Heparin was given intravenously as recommended. Resolute integrity rx catheter entrapment in an ivus was noted. It was stated that the cause of the entrapment was stent under expansion/overlapping stents. The retrieval method was via the buddy wire technique. The stent was removed successfully. No clinical outcomes were reported in the study.
 
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Brand NameRESOLUTE INTEGRITY RX
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key9415131
MDR Text Key169199813
Report Number9612164-2019-05011
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 12/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2019
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

Patient Treatment Data
Date Received: 12/05/2019 Patient Sequence Number: 1
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