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

Catalog Number RONYX45026X

Device Problems Activation, Positioning or SeparationProblem (2906); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2021

Event Type  malfunction  

Event Description

It was attempted to use a resolute onyx coronary drug eluting stent to treat a non calcified, non torturous lesion in the proximal left anterior descending (lad) artery.  abnormalities were reported in relation to anatomy as a large clot in the lad was noted. The device was inspected with no issues. Negative prep was performed with no issues. The lesion was pre-dilated. The device did not pass through a previously-deployed stent. Resistance was not encountered when advancing the device. Excessive force was not used during delivery. It was reported that stent deformation occurred in vivo post deployment. It was reported that the post dilation nc balloon caught the front end of the stent as it was not apposed to the vessel. It was stated that there was resistance expanding the front end of the stent despite multiple inflations at high pressure. The patient is alive with no injury.

Manufacturer Narrative

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

• Brand Name: RESOLUTE ONYX RX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12796025
• MDR Text Key: 284994004
• Report Number: 9612164-2021-04348
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: RONYX45026X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial