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

Model Number RONYX35018UX

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

Event Type  Malfunction  

Manufacturer Narrative

The device returned with a detachment on the hypotube 48. 5cm distal to the strain relief. The hypotube material was oval and jagged on both sides of the detachment site. A kink was evident on the hypotube 4. 5cm proximal to the detachment site. No other damage evident to the remainder of the device. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

During a procedure an attempt was made to use a resolute onyx rx coronary drug eluting stent to treat a lesion in the right coronary artery (rca). The device was inspected with no issues noted. Negative prep was performed without issue. The device was not kinked and re-straightened during use. It was reported that the stent shaft fractured while advancing the device through the guide catheter. It was able to be removed by removing the catheter. The patient was reported to be alive with no injury.

• Brand Name: RESOLUTE ONYX 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: 9361240
• MDR Text Key: 188151249
• Report Number: 9612164-2019-04852
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 11/22/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: RONYX35018UX
• Device Catalogue Number: RONYX35018UX
• Device LOT Number: 0009837501
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/13/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 07/23/2019
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial