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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING Back to Search Results
Catalog Number ERES25014X
Device Problems Fracture; Leak / Splash
Event Date 04/09/2020
Event Type  Malfunction  
Manufacturer Narrative

An image provided is of the luer of an sds device. The lot number on the luer corresponds with the lot number reported. An image provided shows a crack visible on the front of the luer. If information is provided in the future, a supplemental report will be issued.

 
Event Description

An endeavor resolute rx coronary drug-eluting stent was used during a procedure. There was no damage noted to the packaging or any issues noted when removing the device from the hoop. The device was inspected before use with no issues noted. Negative prep was not performed. An attempt was made to connect the luer of the endeavor resolute device to a non-medtronic inflation device. There were no difficulties noted when attaching the luer of the endeavor resolute to the non-medtronic inflation device. No crack was noted prior to attaching the luer of the endeavor resolute to the non-medtronic inflation device. The endeavor resolute was connected to the non-medtronic inflation device using an adapter. Resistance was not encountered when advancing the device and excessive force was not used. It was reported that the luer of the device cracked with an air leak noted during the procedure. The leak was noted to be coming from the luer of the device only. An attempt was made to inflate the balloon. It was stated that the balloon failed to inflate due to the leak coming from the cracked luer. The device and delivery system were removed together from the patient. The patient was reported to be alive with no injury.

 
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Brand NameENDEAVOR RESOLUTE 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 Key10008742
Report Number9612164-2020-01714
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/19/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/29/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberERES25014X
Device LOT Number0009702410
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 Received06/17/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/18/2019
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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