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

Model Number RONYX20012UX

Device Problems Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis summary: there was no evidence of foreign material on the device.The stent was positioned on the balloon between the marker bands as per specifications.There was no deformation evident to the stent.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.There was 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

A resolute onyx rx coronary drug eluting stent was intended to be used.There was no damage noted to device packaging.The device was inspected with no issues noted.No difficulties were noted when removing the stylette or sheath.Negative prep was performed with no issues.The device was used in the patient.It was reported that stent deformation was noted after was removed from the body.It was reported that some white fuzz was noted on the stent.It was uncertain if the material was from a wipe, or the if it was already on the stent.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: 9606957
• MDR Text Key: 188431209
• Report Number: 9612164-2020-00335
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556638
• UDI-Public: 00643169556638
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2021
• Device Model Number: RONYX20012UX
• Device Catalogue Number: RONYX20012UX
• Device Lot Number: 0009956422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2019
• 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