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

Model Number RONYX30022UX

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2020

Event Type  malfunction  

Manufacturer Narrative

No medical/surgical intervention (e.G.Placed on antibiotics) was required as a result of the event.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 the index procedure, one resolute onyx rx coronary des was implanted to treat a non- tortuous, mildly calcified lesion located in the mid left anterior descending (lad) artery.There was no damage noted to the packaging or any issues noted when removing the device from the hoop.The device was inspected and negative prep was performed with no issues noted.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 the stent was used after its expiration date.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: 9580205
• MDR Text Key: 180241127
• Report Number: 9612164-2020-00193
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557000
• UDI-Public: 00643169557000
• 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: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2020
• Device Model Number: RONYX30022UX
• Device Catalogue Number: RONYX30022UX
• Device Lot Number: 0008936975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 01/16/2020
• Supplement Dates FDA Received: 02/11/2020
• Date Device Manufactured: 01/02/2018
• 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