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

Catalog Number RONYX35038X

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

Patient Problems Myocardial Infarction (1969); Stenosis (2263); Patient Problem/Medical Problem (2688)

Event Date 02/09/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the index procedure one resolute onyx stent was implanted into the lad.Approx 8 months post index procedure, the patient suffered a late presentation anterior mi.The mi occurred in the target vessel- lad.Instant restenosis of the stent in the lad was observed.The patient was treated with pci, surgical intervention and medication.The patient recovered.The investigator reported that the event is possibly related to the device and the anti platelet medication.

Manufacturer Narrative

The patient was not treated with pci.The patient had a coronary angiogram.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The patient was not treated with surgical procedure.The patient was treated with pci.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: 8403643
• MDR Text Key: 138228613
• Report Number: 9612164-2019-00819
• 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
• Report Date: 05/24/2019

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: 11/10/2019
• Device Catalogue Number: RONYX35038X
• Device Lot Number: 0008875641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 03/08/2019
• Supplement Dates Manufacturer Received: 03/22/2019; 05/09/2019
• Supplement Dates FDA Received: 04/15/2019; 05/24/2019
• Date Device Manufactured: 11/10/2017
• 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: 66 YR
• Patient Weight: 81