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

Catalog Number ERES22518X

Device Problems Difficult To Position (1467); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2016

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the stent was positioned on the balloon between the marker bands as per specifications.The sheath and stylette were returned in the device; it was not possible to remove the sheath as the stylette was stuck in the guidewire lumen.The sheath could not be removed therefore the distal stent segments could not be exposed or the distal od measured.There was visible deformation to the 6th, 7th, 8th and 9th distal segments with numerous struts raised.(b)(4).

Event Description

It was reported that the physician was attempting to use one endeavor resolute (rx) drug-eluting stent to treat a severely calcified and moderately tortuous lad lesion exhibiting 85% stenosis.The device was removed from its packaging and inspected with no issues noted.It cannot be confirmed if negative prep was preformed.The lesion was pre-dilated.The device did not pass through a previously deployed stent.During the procedure, resistance was encountered during delivery.It was reported that the device failed to cross the target lesion.The physician replaced the device with a non-medtronic stent and completed the procedure without further complication.No patient injury was reported.The physician commented that the event was due to use of the device in difficult lesion morphology/anatomy, i.E.The event was procedural related and not device related.The returned device exhibited deformed stent struts.The physician does believe that the deformation was due to the use of the device in a difficult lesion morphology/anatomy and not device related.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.

• Brand Name: ENDEAVOR RESOLUTE RX
• Type of Device: STENT, 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 Key: 5899603
• MDR Text Key: 52839741
• Report Number: 9612164-2016-00884
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2016
• Device Catalogue Number: ERES22518X
• Device Lot Number: 0007335828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 78