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

Catalog Number RONYX35018UX

Device Problems Difficult to Remove (1528); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problems Occlusion (1984); Chest Tightness/Pressure (2463)

Event Date 02/13/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

At the time of the index procedure, the lad presented with a 60% focal stenosis just beyond the takeoff of the first diagonal branch, with mild to moderate diffuse luminal irregularities out to its apex.The d1 had a 90% ostial stenosis.Moderate plaque burden was seen in all coronary artery trees.The physician implanted one resolute onyx stent (2.75 x 15mm) in the 1st diagonal ostium with no issues noted.However plaque shift and abnormal flow reserve was noted towards the lad, suggesting that the lesion just below the first diagonal artery needed treatment.One cougar guide wire was advanced into the 1st diagonal branch, and then over a pressure monitoring guide wire, a resolute onyx 3.5 x 18mm stent was advanced through the previously deployed stent.While trying to position the stent and retract slightly, the stent became entangled in the previous stent in the 1st diagonal branch.It was not possible to retract or advance the undeployed stent.Attempts to release the trapped stent with the aid of the guide catheter were unsuccessful.The stent now appeared fore-shortened on the balloon.It was decided to deploy the stent at its current location at high pressure but the device appeared damaged on review, although the lesion itself was treated well.It was reported that the majority of the stent was right across the ostium on the first diagonal artery, resulting in closure of the first diagonal artery.Some haziness was noted in the ostium of the 1st diag artery and it was noted that the pile up of metal would increase the risk of thrombosis in to the first diagonal artery.There were no issues with the wire prior to the interaction with the stent.The cougar wire was withdrawn from the 1st diag.The physician attempted to advance it through the side of the stent, but as the stent was deformed, it was difficult to access.The cougar was eventually advanced with moderate difficulty.While attempting to advance a 1.5 balloon across the lad the cougar wire fractured.On withdrawal of the wire, approx.3cm of the tip remained in the 1st diag and could not be withdrawn.Attempts to balloon the 1st diag were unsuccessful.After prolonged attempts with multiple wires and non-medtronic catheters, the procedure was terminated as the patient experienced chest pressure and the 1st diag appeared to be completely occluded.The stent in the lad was further post dilated with a 3.5mm non-compliant balloon due to some lucency visible around the stent.This had also been done previously in the procedure.Marked improvement in flow was seen.The patient has been discharged from the hospital in a stable condition.Received for evaluation was a sprinter legend balloon with the wire caught in the balloon guide wire lumen.

Manufacturer Narrative

Cine image review: the returned procedural images capture the patient lesion condition as reported by the account.A guide wire is delivered to the target lesion followed by the successful implantation of the 2.75 x 15 mm resolute onyx stent.A second guide wire is also visible in the adjacent lesion.A subsequent image captures the 3.5 x 18 mm resolute onyx stent implanted adjacent to the first stent in the 1st diagonal ostium.The stent delivery and expansion were not captured in the images provided.Deformation/bunching is visible on the 3.5 x 18 mm resolute onyx stent.Post dilation is performed using an unknown balloon.An image captures what appears to be the sprinter legend device trapped on the cougar guide wire.The moving image captures a tugging motion on the guide catheter and sprinter legend device, which appears to be an attempt to release the device from the guide wire.The cougar wire appears to be stuck in the previously implanted stents.The detached distal portion of the cougar wire is visible in a later image.Attempts to retrieve the detached guide wire were unsuccessful.The last image captured the reported total occlusion of the 1st diagonal branch, the distal section of the cougar guide wire is also visible in the image and remains in the patient.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 7662400
• MDR Text Key: 113160673
• Report Number: 9612164-2018-01624
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557086
• UDI-Public: 00643169557086
• 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,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2019
• Device Catalogue Number: RONYX35018UX
• Device Lot Number: 0008868013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 11/06/2017
• 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: 70 YR
• Patient Weight: 74