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

Catalog Number RONYX30030X

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Myocardial Infarction (1969)

Event Date 04/05/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the index procedure, one resolute onyx drug eluting stent was implanted in the cx and two resolute onyx drug eluting stents were implanted in the lad.On the same day, the patient suffered a procedure related mi.The investigator assessed the event as possibly related to the index device but not related to anti-platelet medication.Safety assessed the event as possibly related to the index device and causally related to the procedure but not related to anti-platelet medication.The patient recovered.

Manufacturer Narrative

Date mfr rec'd corrected to 2018-07-09.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.

Manufacturer Narrative

Event was treated with medication.Cec adjudicated the event as non-q-wave mi in the lad (target vessel), 3rd umdi.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: 7688654
• MDR Text Key: 114007510
• Report Number: 9612164-2018-01728
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 10/16/2018

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: 02/11/2020
• Device Catalogue Number: RONYX30030X
• Device Lot Number: 0008991415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/15/2018
• Supplement Dates Manufacturer Received: 07/09/2018; 08/08/2018; 09/20/2018
• Supplement Dates FDA Received: 07/15/2018; 10/02/2018; 10/16/2018
• Date Device Manufactured: 02/11/2018
• 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 Age: 66 YR
• Patient Weight: 75