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

Catalog Number RONYX35026X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myocardial Infarction (1969); Thrombus (2101); Patient Problem/Medical Problem (2688)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the index procedure, three non medtronic stents were implanted into the rca, one resolute onyx was implanted into the rca, one non medtronic stent was implanted into the rpl, one non medtronic stent was implanted into the cx and one non medtronic stent was implanted into the 1st obtuse marginal.It was reported that the patient suffered nstemi.Stent thrombosis was observed.The device is unknown.The patient was treated with medication and pci.The patient recovered.

Manufacturer Narrative

Investigator assessed the event as possibly related to the device and anti-platelet medication.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The resolute onyx device was implanted to treat the mi event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The resolute onyx stent was implanted into the rca on the (b)(4) 2019 to treat the mi.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The cec event date of the mi was the (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: cec adjudicated the event date of the mi as the (b)(6) 2019.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: 8394117
• MDR Text Key: 137935769
• Report Number: 9612164-2019-00789
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2020
• Device Catalogue Number: RONYX35026X
• Device Lot Number: 0009471059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2019
• Date Device Manufactured: 12/04/2018
• 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
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 88