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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 ERES35024X
Device Problems Fracture (1260); Migration or Expulsion of Device (1395)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/29/2016
Event Type  Malfunction  
Manufacturer Narrative

Com code: c50190. 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. 5x24mm 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. 25x30mm endeavor resolute, however it failed to cross the lesion and came into contact with the implanted 3. 5x24mm endeavor resolute stent causing the 3. 5x24mm 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. 5x24mm 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

Cine image review: one still image was received from the account. The image captures a stretched and deformed stent in the vessel in the arm as reported by the account. It is indicated that the whole stent remained in the patient's arm.

 
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 Key6192953
MDR Text Key63067581
Report Number9612164-2016-01348
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 02/01/2017
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 Date05/05/2018
Device Catalogue NumberERES35024X
Device LOT Number0008042843
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/05/2016
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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