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

Catalog Number RONYX22522UX

Device Problems Complete Blockage (1094); Material Deformation (2976)

Patient Problems Chest Pain (1776); Occlusion (1984); ST Segment Elevation (2059)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A resolute onyx 2.00x30 mm drug eluting stent was intended to be used during a procedure.The intended lesions were in the mid to proximal lad, with severe tortuosity and severe calcification.There was sequential 70 and 80 % stenosis in the lesions.No damage was noted to packaging.No issues when removing the device from the hoop.Device was inspected without issues.It is reported that stent deformation occurred-longitudinal stent deformation caused by a guide liner and an additional stent was attempted to be overlapped proximally.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during the delivery.A guideliner was used to aid in delivery to the lesion.The device was deployed without issue.When an additional stent was to be put in proximally, the proximal edge of the first stent could not be crossed.There was an attempt with a guideliner to advance the second stent but again, it did not cross.An angiogram was then performed, and it was noted that 4-5mm of one of the stents had crushed upon itself.No damage was noted to the stent that was deployed proximally during advancement/deployment.A stent was deployed proximally and again it was attempted to cross the distal stent.The stent then became occluded and st elevation occurred with chest pain.It was noted that the st elevation resolved after a few minutes.Finally, a small 1.2x8 mm balloon was able to cross, and it opened up the proximal stent edge.Another resolute onyx was placed to bridge the gap between the two stents.No patient injury is reported.

Manufacturer Narrative

Patient history: prior pci.Patient hospitalised with chest pain with an acute non-stemi at time of procedure.Additional updated information: the 2.0x30mm resolute onyx was deployed without issue in the mid lad at 12 atm for 30 secs.The stent that was deployed proximally was a resolute onyx stent (2.25x22mm).The 2.25x22mm resolute onyx stent was deployed in the ostial lad in a non-overlapping fashion, as it could not be advanced into the mid-lad.It was deployed at 12 atm for 30 secs.No damage was noted to this stent.An angiogram was then performed, and it was noted that 4-5mm of the proximal stent edge of the 2.0x30mm stent in the mid lad became longitudinally compressed when trying to advance the proximal lad stent.The proximal 5mm of the mid lad stent became compressed more distally at the proximal edge of the mid lad stent.Subsequent to the proximal lad stent deployment, the lad began to have reduced flow (occlusion).The patient began to have some chest pain and transient st segment elevations.Several attempts were made to advance several balloons past the compressed proximal stent edge in the mid lad.A 1.2x8mm non-medtronic balloon was finally advanced across the proximal stent edge and balloon angioplasty was performed with the 1.2x8mm balloon and other balloons.A 2.25x12mm resolute onyx drug eluting stent was then deployed in the mid lad to bridge the gap between the two stents.The entire stented segment was post dilated with non-medtronic balloons and with the balloon of the 2.25x12mm resolute onyx.The placing of the three overlapping stents was successful.The chest pain and st segment elevations were resolved.The st segment elevations lasted less than 10 mins.The procedure was completed.The patient was in stable condition with no further chest pains.There was no residual stenosis post procedure.No further patient complications reported.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.

Manufacturer Narrative

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

Manufacturer Narrative

Cine image review: the images show the lesion in the lad as reported by the account.Pre dilation of the lad lesion is shown in the images.A stent is delivered and deployed in the mid lad.An attempt is made to deliver a second overlapping stent through the proximal portion of the mid lad stent.The proximal struts of the mid lad stent become compressed as shown by the darker region at the proximal portion of the mid lad stent.A second stent is deployed in the proximal lad.The deformed struts of the mid lad stent are visible in the image.A contrast image is taken and shows reduced flow in the lad vessel at the location of the mid lad stent.A small dilation balloon is passed through the proximal opening of the mid lad stent and retracted repeatedly.An angiogram then shows improved flow in the lad.A third stent is deployed between the mid lad stent and the proximal lad stent.A final angiogram shows the treated lad with improved flow as shown by the flow of contrast through the vessel.There were no images of the proximal lad stent failing to cross the mid lad stent.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: 7684643
• MDR Text Key: 113867810
• Report Number: 9612164-2018-01712
• 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,Followup,Followup,Followup,Followup
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2020
• Device Catalogue Number: RONYX22522UX
• Device Lot Number: 0008982441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2019
• Date Device Manufactured: 02/04/2018
• 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: 78 YR
• Patient Weight: 68