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

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

Patient Problems Atrial Fibrillation (1729); Thrombus (2101)

Event Date 04/14/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the procedure, one resolute onyx drug eluting stent was used to treat a mildly tortuous and calcified lesion, located in the distal right coronary artery, exhibiting 80% stenosis.There were no abnormalities in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.The device was inspected with no issues identified.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did pass through a previously-deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.No issues noted during stent deployment and the resolute onyx was post dilated.Patient had atrial fibrillation (af) at the time of the initial procedure before the lesion was post dilated.It was reported that the patient returned to hospital approximately one month after the initial procedure complaining of chest pain.Cardiac catheterisation was performed.Thrombus was discovered in the very distal portion of the stent.Thrombus was aspirated using a medtronic catheter (export).The patient had af before and after use of the export catheter.The stent was post dilated again.Patient was not on aspirin at time of thrombosis.Patient is not on aspirin and full dosage of eliquis.Patient status is alive with no injury.

Manufacturer Narrative

Cine image review: the images capture thrombus located in the distal rca, in the distal portion of the resolute onyx stent, and in the previously deployed unknown brand stent.The outline of previously deployed stents are visible in the vessel.A medtronic export catheter is used to treat the thrombus.An unidentified balloon is used to post dilate the stent at the site of the thrombus.Post-dilation is continued throughout the proximal rca.The next images capture the blood flow restored throughout the rca, with no evidence of a thrombus.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: 7532544
• MDR Text Key: 108850852
• Report Number: 9612164-2018-01182
• 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: 09/10/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 08/15/2018
• Supplement Dates FDA Received: 09/10/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 79 YR