• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC IRELAND ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING Back to Search Results
Catalog Number ERES35030X
Device Problems Fracture; Inflation Problem
Event Date 04/12/2020
Event Type  Malfunction  
Manufacturer Narrative

The endeavor resolute rx coronary drug eluting stent is similar to the resolute integrity rx coronary drug eluting stent which is marketed in the us. If information is provided in the future, a supplemental report will be issued.

 
Event Description

An endeavor resolute rx coronary drug-eluting stent was intended to be used during a procedure to treat a non-tortuous, non-calcified lesion exhibiting 80% stenosis in the left circumflex (lcx) artery. There was no damage noted to the device packaging. There were no issues noted when removing the device from the hoop. The device was inspected prior to use with no issues noted. Negative prep/purging was performed with no issues noted. The device did not pass through a previously-deployed stent. Resistance was not encountered when advancing the device and excessive force was not used. The luer of the endeavor resolute was connected directly to a non-medtronic inflation device with no issues noted. No crack was noted prior to attaching the luer of the endeavor resolute to the non-medtronic inflation device. It was reported that the luer of the device cracked while attempting to inflate the device. It was also reported that during inflation there was insufficient balloon inflation due to the air leak from the cracked luer. The device was eventually implanted after initial difficulties with insufficient balloon inflation due to cracked luer. The patient was reported to be alive with no injury.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameENDEAVOR RESOLUTE RX
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
IE 
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
IE 
Manufacturer Contact
toni o'doherty
parkmore business park west
galway  
 
091708734
MDR Report Key10047583
Report Number9612164-2020-01861
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 05/12/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/12/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberERES35030X
Device LOT Number0009959102
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 Received05/08/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/08/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-