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

Model Number RONYX27515UX

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

Patient Problems ST Segment Elevation (2059); Thrombus (2101)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A resolute onyx rx coronary drug eluting stent was implanted in the distal circumflex.The lesion exhibited 95% stenosis.There was no damage noted to the packaging.There was no issues noted when removing the device from the hoop.Negative prep was not performed.The device was inspected prior to use with no issues noted.The lesion was pre-dilated.Resistance was not encountered during advancement.No excessive force used during delivery.It was reported that there was a successful initial implant.Closed groin access.Patient half an hour later had inferior st elevation.Patient was brought back into procedure room for investigation.Noted acute stent thrombosis.Ivus performed.Noted that stent needed to be post dilated for better apposition with nc balloon.Initial deployment at nominal pressure only.Patient discharged and stable.

Manufacturer Narrative

The stent was fully apposed when initially deployed.The stent was not post-dilated.The patient was on dapt when this thrombotic event occurred.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: 7915075
• MDR Text Key: 121907231
• Report Number: 9612164-2018-02553
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RONYX27515UX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2018
• 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): Required Intervention