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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 RSINT30038X
Device Problems Fracture (1260); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/29/2020
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 a severely tortuous, severely calcified lesion located in the left anterior descending (lad) artery. The device was inspected with no issues noted. It was reported that a coronary angiography was performed on the patient for myocardial infarction. A severe injury to the descending artery in bifurcation with diagonal branch was noted. It was stated that attempts to advance the resolute integrity stent were unsuccessful due to high tortuosity and calcification. It was stated that damage to the stent structure occurred and the stent was noted to be fractured/broke. The stent was not implanted and was replaced with another device. There was no surgical or medical intervention needed to prevent a permanent impairment of a function. 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
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key10360902
MDR Text Key201547914
Report Number9612164-2020-02862
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeAR
PMA/PMN NumberP110013
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 08/24/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/04/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRSINT30038X
Device LOT Number0010012176
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 Received08/05/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/12/2019
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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