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

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Intimal Dissection (1333); Death (1802); Thrombus (2101)

Event Date 03/15/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

During the procedure, one resolute onyx rx drug eluting stent was used to treat a to treat a lesion.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre-dilated.There was no resistance noted when advancing the device to the lesion.The stent was deployed at 12 atm.It was not post-dilated.It was reported that the patient had stent thrombosis 48 hours after stent implantation.The patient was on dapt.The patient was brought to the lab to treat the stent thrombosis.It was reported that the onyx was undersized.The cine images of the implant procedure were reviewed by the account.It was reported that there was an edge dissection proximal to the stent.Another medtronic stent was placed to treat the dissection.The dissection had been missed on the last pictures in the first case.The patient needed ecmo for extra support.It was reported that the patient died during the second procedure to open the thrombosis.The ecmo device was not inserted correctly causing the patient to bleed and unrecover.The patient expired.

• 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: 7432079
• MDR Text Key: 105505761
• Report Number: 9612164-2018-00796
• 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
• Report Date: 04/16/2018

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2018
• Initial Date FDA Received: 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 Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention