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

Catalog Number RONYX30038UX

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/30/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a procedure an attempt was made to use a resolute onyx rx coronary, drug eluting stent to treat a severely tortuous, severely calcified lesion exhibiting 100% stenosis in the proximal saphenous vein graft (svg).The patient had previous stents deployed.The device was inspected with no issue.Negative prep was performed.The lesion was pre-dilated.The device passed through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was used during delivery.It was reported that stent dislodgement occurred during delivery to the lesion.The stent was catching on a previously deployed stent.Multiple buddy wires were used to try to advance the stent.When removing the stent it was noted that the stent had come off the delivery system.An attempt was made to balloon the stent open.The proximal end of the stent opened but it was not possible to balloon the distal segment.The dislodged stent remains in the patient.No further patient injury reported.

Manufacturer Narrative

The inflation device remained on neutral pressure during delivery of the device.The dislodged stent was deployed inside another stent in the vein graft and remains in the patient.No further interventions are planned because patient is doing fine per physician.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: 8526349
• MDR Text Key: 142334772
• Report Number: 9612164-2019-01401
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RONYX30038UX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2019
• 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
• Patient Outcome(s): Required Intervention