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

Catalog Number ERES22524X

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2016

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: there was 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 13th distal stent segment was deformed with raised struts.No other damage was noted on the device.(b)(4).

Event Description

The physician was attempting to use an endeavor resolute drug eluting stent during a procedure to treat a lesion in the moderately tortuous cx.The lesion exhibited 85-90% stenosis and severe calcification.The lesion was pre-dilated.No damage was noted to packaging.No issues were noted when removing the device from the hoop/tray.The device was inspected with no issues noted.Negative prep was preformed with no issues noted.Resistance was encountered when advancing the device.It is unknown if excessive force was used.It is reported that the stent deformed in vivo during positioning.The stent couldn't pass through the lesion and after the pulling back the system, damage to the stent struts was seen.No patient injury.The physician believes 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 physician completed 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: 5900178
• MDR Text Key: 52870973
• Report Number: 9612164-2016-00890
• 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: 08/10/2016
• Device Catalogue Number: ERES22524X
• Device Lot Number: 0007253161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2014
• 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
• Patient Weight: 80