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

Catalog Number RONYX27530JX

Device Problems Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Thrombus (2101)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a procedure a resolute onyx coronary drug eluting stent was used to treat a moderately tortuous and calcified lesion exhibiting 75% stenosis located in the left main (lm) coronary artery, and proximal-mid lad.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 while advancing the device.Excessive force was not used during delivery.After pre-dilation was performed a 2.25x38mm non-medtronic stent was implanted in the mid-distal lad.Dilation was carried out several times for proximal-mid lad using a 2.0x15mm non-medtronic balloon from 10-16atm.The resolute onyx 2.75x30mm stent was next implanted in the proximal-mid lad at 12atm.A 4.0x15mm non-medtronic balloon was then implanted in the left main trunk (lmt) ostium of lad to overlap the resolute onyx.A 4.0mm stent balloon was inflated at 6 atm in the overlapping part.Thereafter the stent balloon reached the lmt and was inflated to 20 atm.Thereafter, kissing balloon technique (kbt) was performed at lmt.An angiography was performed and showed that there were no issues and that all stents were sufficiently adhered to the vessel wall.The procedure was completed.It was reported that 7 days post procedure the patient presented with chest pain.A coronary angiography (cag) was performed showing an in stent thrombosis in the overlapping part of the stent.The thrombosis was treated by aspiration.Ivus was performed and showed that there was insufficient post dilation and that the overlapping portion of the stent was not sufficiently expanded.Post dilation was performed several times from 16atm to 23atm with a 2.5x15mm nc balloon, timi 3 flow developed, and then, the dilation was performed in lmt with a 4.0x15mm nc balloon.Post dilation was also performed in the proximal-mid lad using 3.0x15mm nc balloon at 23atm.Ivus was performed and showed that the stent expanded well.An angiography was performed with no issues noted and the procedure was completed.The patient is reported to be alive.No further patient injury has been reported.

Manufacturer Narrative

Correction: a 4.0 x 15mm non-medtronic stent was then implanted in the left main trunk (lmt) ostium of lad to overlap the resolute onyx.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The device was being used to treat a lesion exhibiting 90% stenosis.The patient was treated with dapt post implantation.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: 8154718
• MDR Text Key: 130033746
• Report Number: 9612164-2018-03575
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2020
• Device Catalogue Number: RONYX27530JX
• Device Lot Number: 0008962808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2019
• Date Device Manufactured: 01/24/2018
• 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): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 60