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

Catalog Number ERES35024X

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2016

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: there is no damage to the distal tip of the device.The stent was positioned on the balloon between the inner shaft markers as per specification requirement.The 12th -15th distal segments were deformed with slightly raised struts.The 16th distal stent segment was also deformed with raised struts.Stent od¿s: proximal stent od is 0.045inch 16th distal segment od is 0.060inch.Distal stent od is 0.045inch.Specification is 0.055 inch max.Com code: (b)(4).

Event Description

It was reported that the physician was attempting to use two endeavor resolute drug eluting stents to treat a patient.The lesion was situated in the lad and exhibited 90% occlusion, calcification and normal tortuosity.Both devices were removed from their packaging and inspected with no issues noted.The target lesion was pre-dilated using a euphora balloon catheter prior to delivery of the endeavor resolute devices.Resistance was encountered when advancing the devices and excessive force was used.It was reported that both devices failed to cross the target lesion.No patient injury reported.The physician did not complete the procedure.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: 5754440
• MDR Text Key: 48292892
• Report Number: 9612164-2016-00621
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2017
• Device Catalogue Number: ERES35024X
• Device Lot Number: 0007858766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2015
• 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: 65 YR
• Patient Weight: 62