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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 ERES22524X
Device Problems Difficult To Position; Material Deformation
Event Date 07/25/2016
Event Type  Malfunction  
Manufacturer Narrative

Evaluation summary: there was no damage to the distal tip of the device. The stent was positioned on the balloon between the inner shaft markers as per specification requirement. The 13th distal stent segment was deformed with raised struts. No other damage was noted on the device. (b)(4).

 
Event Description

The physician was attempting to use an endeavor resolute drug eluting stent during a procedure to treat a lesion in the moderately tortuous cx. The lesion exhibited 85-90% stenosis and severe calcification. The lesion was pre-dilated. No damage was noted to packaging. No issues were noted when removing the device from the hoop/tray. The device was inspected with no issues noted. Negative prep was preformed with no issues noted. Resistance was encountered when advancing the device. It is unknown if excessive force was used. It is reported that the stent deformed in vivo during positioning. The stent couldn't pass through the lesion and after the pulling back the system, damage to the stent struts was seen. No patient injury. The physician believes 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 physician completed the procedure. 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 Key5900178
Report Number9612164-2016-00890
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 Date08/10/2016
Device Catalogue NumberERES22524X
Device LOT Number0007253161
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/03/2016
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 Manufactured08/11/2014
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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