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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 ERES30030X
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2016
Event Type  Malfunction  
Manufacturer Narrative

Still image review: the returned images appear to show stent deformation of the middle section of the complaint device. (b)(4).

 
Event Description

The procedure was prompted by acute coronary syndrome. It was reported that the physician was attempting to use an endeavor resolute rx drug eluting stent to treat a lesion in the middle of the rca with 99% stenosis, slight calcification and tortuosity. No issues noted during inspection prior to use. Lesion was pre-dilated. Resistance was noted while advancing to the lesion, no excessive force was used. It was reported that during the procedure, the stent deformed during positioning. The physician replaced it with another stent to complete the operation. No patient injury was reported as a result of the event 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

The stent was positioned on the balloon between the marker bands as per specifications. There was deformation to the 16th and 17th distal stent wraps with struts raised. The distal shaft was kinked 7. 9cm and 8. 8cm distal to the guidewire entry port. There was slight deformation to the distal tip. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
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 Key6188428
MDR Text Key62790825
Report Number9612164-2016-01333
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeCH
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,Followup
Report Date 01/17/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/20/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/07/2018
Device Catalogue NumberERES30030X
Device LOT Number0008005126
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/06/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/07/2016
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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