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

Catalog Number RONYX30022UX

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

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); ST Segment Elevation (2059); Thrombus (2101)

Event Date 03/29/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

A 3.0x22mm resolute onyx drug eluting stent was used to treat a mildly tortuous, moderately calcified lesion with 75% stenosis in the proximal lad.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop/tray.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device and excessive force was not used.Two vessels were stented, the first used a 3.0x12mm non-mdt device on a first marginal off the lcx.The proximal lad was then pre-dilated and a resolute onyx drug eluting stent was implanted.Hours later the patient was experiencing pain and ekg changes so they were brought back to the cath lab and the physician found that the mid-stent has a non-occlusive clot and still had timi 3 flow through the stent and down the vessel.The physician used a non-mdt aspiration catheter to suck the clot out of the vessel and a 3.75x15mm non-mdt balloon was used in the mid stent section.Another picture was taken and a 4.0x12mm non-mdt balloon was used to further post-dilate the stent at 16 atm, the patient had timi 3 flow leaving the cath lab.The patient was brought back to the cath lab the following morning and the onyx was found to be fully open and clot free.Before the intervention the patient was on aspirin and integrilin and on brilinta following the procedure.The patient was discharged and was reported to be fine post procedure.There is no alleged product issue.The physician did not blame the resolute onyx for the event.

Manufacturer Narrative

Additional information: the patient presented with non-stemi.The patient was noted to be restless on the cath lab table.Blockages were noted on catheterisation.It was reported that the resolute onyx was sized correctly for the lesion,and looked good post implantation.The patient experienced st elevation, along with the previously reported pain and ekg changes.The patient was not on anything before the initial procedure.It was subsequently reported that approx 1-2 days post implantation the patient had impaired kidney function.The patient¿s family decided to withdraw treatment due to the patient¿s comorbidities.It was reported that the patient passed away soon after.Date of death: month and year valid.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the cause of death was cardiopulmonary arrest.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: review of the procedural images provided confirm the presence of a calcified stenotic lesion in the proximal left anterior descending artery (lad) and in the obtuse marginal branch of the lcx.Pre-dilation of the om was carried out and that can be confirmed from the images provided.First stent was deployed in the om of the lcx and the second stent was deployed in the proximal to mid lad and that can be confirmed from the images provided.Post deployment stent observation was good, according to the surgeon.It was reported that hours later patient had ecg changes so another catheterisation was performed, and the existence of the clot in the mid lad stent was perceived.It was reported that the clot was sucked with the aspiration catheter but there are no images provided.Stent was further post dilated and that can be confirmed from the images provided.It was reported that as a precaution the patient was brought back to the catheterisation laboratory the following morning and the stent in the lad was found to be fully open and clot free and that can be confirmed from the images provided.Nevertheless, calcified nature of the lesion in lad can be confirmed from the images provided.The review of the images provided can confirm the presence of the stenotic lesion in the proximal left anterior descending artery (lad) and a stenotic lesion in the obtuse marginal (om) branch of the lcx.Images of the stent deployment in om and lad artery were provided.Following images can confirm existence of the potential clot in the mid lad, without contrast staining.No images of clot extraction provided.Final images of the stenosis resolution were provided.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: 7464640
• MDR Text Key: 106614111
• Report Number: 9612164-2018-00922
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557000
• UDI-Public: 00643169557000
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2020
• Device Catalogue Number: RONYX30022UX
• Device Lot Number: 0008937006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2018
• Date Device Manufactured: 01/02/2018
• 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