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

Catalog Number ERES27518X

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the distal tip of the device is damaged as the stylette could not be removed due to hardened blood/contrast.The stent was positioned on the balloon between the inner shaft markers as per specification requirement.The 11th distal stent segment was deformed with raised struts.(b)(4).

Event Description

It was reported that the physician was attempting to use an endeavor resolute rx drug eluting stent to treat a severely calcified and moderately tortuous lad lesion exhibiting 75% stenosis.The lesion had been pre-dilated.The device was removed from its packaging as per ifu and inspected with no issues noted.It was reported that resistance was encountered when advancing the device and it was reported that the stent deformed in-vivo during positioning.The device was replaced with another endeavor resolute to complete the procedure.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.No patient injury reported.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: 5789665
• MDR Text Key: 49375589
• Report Number: 9612164-2016-00675
• 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: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2016
• Device Catalogue Number: ERES27518X
• Device Lot Number: 0007197833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2014
• 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: 55 YR