MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY OTW; STENT, CORONARY, DRUG-ELUTING

Catalog Number RSINT40012W

Device Problems Difficult to Insert (1316); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2014

Event Type  malfunction  

Event Description

Evaluation summary: the distal portion of the stent was damaged.The proximal portion of the stent is damaged.

Manufacturer Narrative

Evaluation results: related to operational context ¿ pulling the undeployed stent back into the guide catheter may have deformed the stent struts.Evaluation conclusions: related to operational context ¿ pulling the undeployed stent back into the guide catheter may have deformed the stent struts.(b)(4).

Event Description

Physician was attempting to implant one resolute integrity drug-eluting stent (4.00mm x 12mm) to a little calcified lesion in the lad with moderate tortuosity but the device could not cross.The device was inspected before use with no issues noted.The device was withdrawn and the guidewire was repositioned.When the device was re-advanced there was resistance noted just outside the guide catheter.The stent was removed and noted to be deformed.Another stent was used to complete the procedure.The physician felt that pulling the undeployed stent back into the guide catheter may have deformed the stent struts.

Manufacturer Narrative

Evaluation results: (root cause of the event could not be determined).Inherent risk of procedure ¿ (stent deformation <(>&<)> failure to deliver the stent).(no results available since no evaluation performed) - device or procedural images not provided for review.Device not returned for evaluation.Evaluation conclusions: inherent risk of procedure ¿ (stent deformation <(>&<)> failure to deliver the stent).(root cause could not be determined).Unable to confirm complaint - (device or procedural images not provided for review).Device not returned - (device not returned for evaluation).(b)(4).

• Brand Name: RESOLUTE INTEGRITY OTW
• 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: 4482102
• MDR Text Key: 5522824
• Report Number: 9612164-2015-00151
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2015
• Device Catalogue Number: RSINT40012W
• Device Lot Number: 0006973829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2013
• 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