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

Catalog Number RONYX22526X

Device Problem Use of Device Problem (1670)

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

Event Date 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a procedure, one resolute onyx rx coronary drug eluting stent was implanted to treat a lesion. There was no damage noted to the packaging. There were no issues noted when removing the device from the hoop. The device was inspected with no issues noted. Excessive force was not used during delivery. It was reported that the expiry date was read incorrectly and the stent had expired by 20 days when it was implanted. The patient as 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 ; 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: 11419744
• MDR Text Key: 235001750
• Report Number: 9612164-2021-00878
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P160043
• 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: 03/23/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/11/2021
• Device Catalogue Number: RONYX22526X
• Device Lot Number: 0009751580
• 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: 03/07/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 02/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial