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

Model Number RONYX25038X

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

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

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the index procedure six resolute onyx des were implanted in the rca.Approx.5 months post index procedure, the patient suffered non st elevation mi.Angiogram showed 70% in-stent restenosis in the rca.The mi occurred in the target vessel.The patient was treated with medication and pci.The investigator assessed the event as possibly related to the device and antiplatelet medication.The patient recovered.

Manufacturer Narrative

It was indicated that a resolute onyx des was implanted in the rca to treat the event.Sponsor assessed the event as not related to the antiplatelet medication and possibly related to the device.Cec adjudicated target vessel mi- rca.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

During the index procedure two resolute onyx des were implanted in the rca, not six as previously reported.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Cec adjudicated q-wave mi, 3rd udmi spontaneous, and clinically driven tlr - percutaneous intervention of the prox rca.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: 8109811
• MDR Text Key: 128560047
• Report Number: 9612164-2018-03387
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2019
• Device Model Number: RONYX25038X
• Device Catalogue Number: RONYX25038X
• Device Lot Number: 0008863677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 02/15/2019; 05/23/2019; 07/23/2019
• Supplement Dates FDA Received: 03/14/2019; 06/14/2019; 08/12/2019
• Date Device Manufactured: 11/02/2017
• 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: 72 YR
• Patient Weight: 57