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

Catalog Number RONYX20015UX

Device Problems Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a procedure a resolute onyx rx coronary, drug eluting stent was used to treat mild calcified, moderate tortuosity, lesion exhibiting 80% stenosis in the ostium of the diagonal branch.The device was inspected with no issues.The lesion was not pre dilated.The device passed through a previously deployed stent.Excessive force was not used.Resistance was not encountered when advancing the device.An attempt was made to deployed the stent at the ostium of the diagonal branch through a previously deployed stent.The stent was deployed at 14 atm.The stent appeared to remain inside of the markers.It is reported that when the balloon was deflated the stent had migrated distally by 3-4mm and shown outside the distal marker and inside the proximal marker.The stent appeared regular length.The stent migrated or became dislodged and migrated.The stent remains in the patient.The procedure was completed using a non medtronic stent.The patient is alive with no injury.

Manufacturer Narrative

Image review: images show cto of the lad.A pre-dilatation balloon inflated across the lesion resolving the cto in the lad.An ostial lesion of the first diagonal artery is then evident in the images.A second guide wire is delivered into and across the lesion.Another balloon is used to pre dilate the artery.The second guide wire is withdrawn back to the left main.A stent is delivered to the lad and deployed.A stent is delivered to the artery.The stent is deployed.The second guide wire is delivered back into the artery and a guide extension catheter (gec) has been introduced into the lad, suggesting that difficulty may have been encountered with re-positioning of the second guide wire.A balloon is firstly delivered to the ostium a, followed by withdrawal of the balloon and the stent delivery to the artery.The gec is deep seated at the proximal end of the newly deployed lad stent the proximal portion of the stent body is positioned at the ostium.There is approximately a four (4) minute gap between this and the next images provided.In the next images the deployed stent appears to have moved distally in the vessel, as there is a gap visible between the proximal portion of the stent body and the ostium of the vessel.This confirms the issue as reported from the account.It is not possible to determine from the images what occurred between the initial stent positioning nad deployment and the image where the stent has moved distally.The gec has been withdrawn in the most recent image.The possibility exists that movement of the gec or the procedural wire may have contributed to the stent movement.But this cannot be confirmed.The possibility exists that the inflation pressure applied to the stent delivery system balloon may not have been sufficient to fully appose the stent to the vessel wall and that it moved when the balloon was deflated.But this cannot be confirmed.Further post dilatation of the lad stent is performed, followed by post dilation of the stent.Another stent is delivered to the ostium and the gap between the stent deployed in the artery.A final angiogram of the lad shows good flow with good deployment profiles of the newly deployed stents.There is a lesion visible in the ostium.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Negative prep was performed.The inflation device remained on neutral pressure during delivery of the device.The stent had migrated distal to the ostium of the diagonal by 5mm.The stent dislodgement occurred in the target lesion during balloon inflation.The stent was secured into vessel wall with the stent balloon.No intervention was carried out to attempt to remove the stent.A non medtronic stent was implanted to cover the ostium that was missed.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): MEDTROINC IRELAND; mexico
• Manufacturer (Section G): MEDTROINC IRELAND; mexico
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8669641
• MDR Text Key: 147510690
• Report Number: 9612164-2019-02162
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RONYX20015UX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2019
• 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