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

Catalog Number RONYX27530UX

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

Patient Problems Myocardial Infarction (1969); Occlusion (1984); Thrombus (2101); Injury (2348)

Event Date 12/17/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a procedure a patient was implanted with two resolute onyx rx coronary drug eluting stents to treat a mildly calcified, mildly tortuous lesion with 95% stenosis located in the ostium of the diagonal branch (ronyx22522ux) and ostium - proximal left anterior descending (lad) artery (ronyx27530ux).The devices were inspected with no issues noted.Negative prep was performed without issue.The lesion was pre-dilated.Resistance was not encountered and excessive force was not used during delivery.No issues were noted during stent deployment.The stents were fully expanded.0% residual stenosis was noted post intervention it was reported that stent thrombosis of the proximal lad stent extending into and occluding the diagonal branch occurred (0-24 hours post stent implantation).Myocardial infarction (12 hours post stent implantation) related to the target vessel also occurred.The event was treated with aspiration, re-dilation of the stents and medication.The patient was on dapt when the thrombotic event occurred.The patient was reported to be alive with no further injury.The physician did not assess that the mi event was directly related to the use of the relevant device.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10055871
• MDR Text Key: 193309395
• Report Number: 9612164-2020-01881
• 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: 05/14/2020

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 Catalogue Number: RONYX27530UX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2020
• Initial Date FDA Received: 05/14/2020
• 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): Other; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 67