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

Catalog Number RONYX30008X

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

Patient Problem Myocardial Infarction (1969)

Event Date 08/03/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During index procedure, three resolute onyx drug eluting stents were implanted; two in the cx and one in the lcma. It was reported that a grade c dissection occurred in the cx. The dissection is reported to have occurred secondary to pre-dilation and was not caused by the stents implanted. The dissection was not caused by a medtronic device. The patient suffered an mi which was reported to be related to this dissection. The investigator assessed the event as not related to the index device or anti-platelet medication. Safety assessed the event as not related to the to the device and not related to anti-platelet medication. The patient recovered.

Manufacturer Narrative

The patient¿s indication for index pci was an nstemi. No mi has been reported as adverse event. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The dissection is reported to have occurred due to the predilation balloon. 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: 8188785
• MDR Text Key: 131126688
• Report Number: 9612164-2018-03753
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/15/2020
• Device Catalogue Number: RONYX30008X
• Device Lot Number: 0009080927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/23/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/21/2018 Patient Sequence Number: 1