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

Model Number RONYX20030UX

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A resolute onyx drug eluting stent was intended to be used to treat a lesion patient's proximal ramus which had no tortuosity, no calcification and 70% lesion stenosis.No abnormalities were reported in relation to the anatomy.No damage was noted to packaging.No issues were noted when removing the device from the hoop/tray.The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device and excessive force was not used.It was reported that the stent did not cross the lesion.Upon removal from the patient, it was noted that the stent had a lifted strut.Another medtronic stent was used to complete the procedure.The patient is alive with no injury.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

Product analysis summary: there was a kink on the catheter 39cm distal to the strain relief.There was a kink on the distal shaft 37.2cm proximal to the distal tip.The stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 14th and 23rd distal stent wraps with struts raised.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.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: 7689918
• MDR Text Key: 114408525
• Report Number: 9612164-2018-01754
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556683
• UDI-Public: 00643169556683
• 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
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2020
• Device Model Number: RONYX20030UX
• Device Lot Number: 0008951771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2018
• 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 Age: 50 YR