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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 ERES25030X
Device Problems Difficult To Position; Material Deformation
Event Date 06/27/2016
Event Type  Malfunction  
Manufacturer Narrative

Evaluation summary: the stent was positioned on the balloon between the marker bands as per specifications. There was visible deformation to the 7th distal stent segment with numerous struts overlapping. The distal tip was not damaged. A protective sheath of similar dimensions could not be loaded onto the stent due to the deformation. (b)(4).

 
Event Description

It was reported that the physician was attempting to use a sprinter legend rx balloon to treat a severely calcified and tortuous lad lesion exhibiting 90% stenosis. It was reported that no abnormalities were noted during inspection prior to use. The lesion was pre-dilated 3 times by a 2. 0 x 30mm sprinter legend balloon catheter and a 2. 5 x 30mm sprinter legend balloon catheter. The lesion was pre-dilated to 10atm for 5 seconds, 10 atms for 8 seconds, and 14 atm for 5 seconds. 50% stenosis remained after pre-dilation. During the operation, resistance was noted while advancing the device. The stent could not cross the lesion. The device was removed from patient. It was replaced by another stent to complete the operation. The physician commented that the event was related to patient's severe vessel tortuosity. No patient injury was reported as a result of the event. When the device was returned to the manufacturing facility, it was noted that the stent was damaged. 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

Correction: the physician was attempting to use an endeavor resolute drug eluting stent to treat the target lesion, and not a sprinter legend balloon, as previously reported.

 
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 Key5899592
Report Number9612164-2016-00883
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,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 Date10/28/2017
Device Catalogue NumberERES25030X
Device LOT Number0007807195
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/08/2016
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 Manufactured10/29/2015
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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