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

Model Number RONYX40018UX

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2020

Event Type  malfunction  

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 one resolute onyx rx coronary drug eluting stent to treat a lesion located in the right coronary artery (rca). It was reported that the resolute onyx stent was expired approximately 6 weeks at the time the stent was implanted. It was stated that the use by date was not checked prior to opening the box of the stent. The patient was reported to be alive with no injury.

Manufacturer Narrative

Additional information: there was no patient injury or medical/surgical intervention as a result of the event. If information is provided in the future, a supplemental report will be issued.

• 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: 10060459
• MDR Text Key: 191746646
• Report Number: 9612164-2020-01886
• 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: 06/08/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/02/2020
• Device Model Number: RONYX40018UX
• Device Catalogue Number: RONYX40018UX
• Device Lot Number: 0009059706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/15/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial