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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 ERES22518X
Device Problems Difficult To Position; Material Deformation
Event Date 07/03/2016
Event Type  Malfunction  
Manufacturer Narrative

Evaluation summary: the stent was positioned on the balloon between the marker bands as per specifications. The sheath and stylette were returned in the device; it was not possible to remove the sheath as the stylette was stuck in the guidewire lumen. The sheath could not be removed therefore the distal stent segments could not be exposed or the distal od measured. There was visible deformation to the 6th, 7th, 8th and 9th distal segments with numerous struts raised. (b)(4).

 
Event Description

It was reported that the physician was attempting to use one endeavor resolute (rx) drug-eluting stent to treat a severely calcified and moderately tortuous lad lesion exhibiting 85% stenosis. The device was removed from its packaging and inspected with no issues noted. It cannot be confirmed if negative prep was preformed. The lesion was pre-dilated. The device did not pass through a previously deployed stent. During the procedure, resistance was encountered during delivery. It was reported that the device failed to cross the target lesion. The physician replaced the device with a non-medtronic stent and completed the procedure without further complication. No patient injury was reported. The physician commented that the event was due to use of the device in difficult lesion morphology/anatomy, i. E. The event was procedural related and not device related. The returned device exhibited deformed stent struts. The physician does believe that the deformation was due to the use of the device in a difficult lesion morphology/anatomy and not device related. Please note that this device, endeavor resolute is not marketed in the united states; however, it is similar to the united states marketed product resolute integrity. This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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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 Key5899603
Report Number9612164-2016-00884
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/26/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/24/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/17/2016
Device Catalogue NumberERES22518X
Device LOT Number0007335828
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/19/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/18/2014
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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