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

Catalog Number RSINT30030X

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An attempt was made to use a resolute integrity rx coronary drug eluting stent to treat a non-tortuous and mildly calcified lesion. The device was inspected with no issues noted. Negative prep was not performed. The lesion was pre-dilated. The device did not pass through a previously-deployed stent. Resistance was encountered but no excessive force used. It was reported that stent deformation occurred due to the use of the device in a tight lesion. The stent was replaced by another manufacturer's device to complete the procedure. The physician assessed that the event was due to use of device in difficult lesion. No patient injury was reported.

Manufacturer Narrative

The stent was positioned on the balloon between the marker bands as per specifications. Deformation was evident to the 11th distal stent wraps with struts raised. No deformation was evident to the distal tip. The inner lumen patency could not be verified with a 0. 015 inch mandrel most likely due to hardened blood in the guidewire lumen. No other damage evident to the remainder of the device. If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE INTEGRITY 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: 8188756
• MDR Text Key: 131177980
• Report Number: 9612164-2018-03752
• 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

• Type of Report: Initial,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/18/2021
• Device Catalogue Number: RSINT30030X
• Device Lot Number: 0009191525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial