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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 ERES22530X
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 11/29/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Product analysis: the stent was not present on the balloon. The stent was returned separately. The stent was stretched, bunched and deformed. Crimp im pressions were visible on the exposed balloon surface. The balloon folds remained intact. There was no indication that the device had previously been inflated. There was 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.

 
Event Description

A 3. 5x24 mm endeavor resolute rx drug eluting stent was implanted successfully in a mildly calcified lcx. Device was inspected before use with no issues noted. Lesion was pre-dilated. No resistance was noted advancing to the lesion. It was then attempted to implant a second device, a 2. 25x30 mm endeavor resolute, however it failed to cross the lesion and came into contact with the implanted 3. 5x24 mm endeavor resolute stent causing the 3. 5x24 mm stent to be pulled into the brachial artery. The 2. 25x30 stent had started to move on the balloon off the stent delivery system and dislodged. A new balloon was used to retrieve the dislodged stent, pulling it into the guide catheter. It was retrieved successfully. The 3. 5x24 mm stent broke in half on removal, with half remaining in the patients arm. No action was taken to remove the this portion from the patients arm. The other half was pulled out and removed from the patient. Patient status is reported as good. 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 Key6192933
MDR Text Key63074147
Report Number9612164-2016-01347
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
Report Date 12/02/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/24/2018
Device Catalogue NumberERES22530X
Device LOT Number0007952133
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/09/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/25/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/21/2016 Patient Sequence Number: 1
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