• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC IRELAND ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING Back to Search Results
Catalog Number ERES25024X
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 12/01/2016
Event Type  Malfunction  
Manufacturer Narrative

Evaluation summary: the dislodged stent returned stretched, bunched and deformed. Crimp impressions were visible on the exposed balloon surface. There was deformation to the distal tip. (b)(4).

 
Event Description

The physician used an endeavor resolute drug-eluting stent to treat a severely calcified and tortuous diffuse mid lad lesion exhibiting 80% stenosis and 50% stenosis in the proximal left main. The device was inspected prior to use with no issues noted. A guidewire was delivered to the distal lad. The physician pre-dilated the lesion using a non-mdt balloon. 70% stenosis remained after pre-dilatation. It was reported that difficulties were encountered while attempting to deliver the endeavor resolute stent. The stent could not reach the target lesion. The stent reportedly dislodged during withdrawal. The physician used a balloon to inflate and successfully withdraw the dislodged stent into the guide catheter. It was reported that due to vascular factors, the stent dislodged again into the brachial artery. The physician used a snare to retrieve the stent. The physician continued the procedure using a guide catheter implanting 2 x endeavor resolute stents and 1 x non-mdt stent to complete the procedure with no stenosis remaining. The physician commented that the severe calcification and possible stent deformation was a contributing factor. 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6188805
MDR Text Key62857200
Report Number9612164-2016-01338
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 12/06/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/08/2018
Device Catalogue NumberERES25024X
Device LOT Number0008007187
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/16/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/08/2016
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: 12/20/2016 Patient Sequence Number: 1
-
-