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

Catalog Number RONYX35012UX

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

Patient Problems Intimal Dissection (1333); Myocardial Infarction (1969); Thrombus (2101)

Event Date 12/06/2017

Event Type  Injury  

Event Description

Two resolute onyx drug eluting stent devices ((b)(4)) were used to treat a moderately tortuous, mildly calcified lesion with 90% stenosis in the mid/proximal circumflex artery.The second stent was placed proximal to the first stent.There was no damage noted to the device packaging and no issues noted when removing the devices from the hoop/tray.The devices were inspected with no issues.Negative prep was not preformed on the devices.The lesion was pre-dilated using a 3.0x12mm sprinter legend.The device did not pass through a previously deployed stent.There were no abnormalities in relation to anatomy.Resistance was not encountered when advancing the device and excessive force was not used.The lesion was post-dilated with a 4.0x8mm nc euphora.It is reported that the patient developed worsening chest pain and ekg changes while in recovery after successful implantation of the two stents.The patient was then brought back to the cath lab where it was noted that dissection and thrombus had occurred 15-20 mm distal to the previously deployed stents; distal to the lowest placed stent.A third resolute onyx device ((b)(4)) was implanted to treat the observed dissection, and this stent was post-dilated with a 3.5x6mm sprinter balloon.The physician has stated that he does not think that the event was caused by the stents and no dissection was noted on the post films from the previous procedure.Heparin and plavix were administered during the procedure.No further patient injury is reported.

Manufacturer Narrative

Image review: the images capture the moderately tortuous lesion with severe stenosis.Pre-dilation and successful stent implantation of two resolute onyx stents are visible in the images.The images captured improved flow post stent implantation with no dissection or thrombus present.Images from the follow up procedure later in the same day capture the reported dissection and thrombus distal to the implanted stents.The dissection is successfully treated with a stent, the images show improved flow post dissection treatment.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: 7129131
• MDR Text Key: 95230702
• Report Number: 9612164-2017-02020
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557062
• UDI-Public: 00643169557062
• 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: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2019
• Device Catalogue Number: RONYX35012UX
• Device Lot Number: 0008788153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• Date Device Manufactured: 09/08/2017
• 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
• Patient Age: 65 YR