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

Model Number RONYX30022X

Device Problems Failure to Advance (2524); Material Deformation (2976); Material Protrusion/Extrusion (2979); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an attempt was made to use a resolute onyx drug eluting stent to treat a lesion in a non-tortuous proximal r-pda with moderate calcification with 80% stenosis.No abnormalities were noted in the patient¿s anatomy.No damage was noted to packaging.The device was inspected with no issues noted.Negative prep was not performed.The lesion was predilated.The device did not pass through a previously deployed stent.Resistance was noted when advancing the device, and excessive force was not used.It was reported that the stent failed to cross the lesion despite multiple attempts and techniques.When it was removed from the patient, a protruded stent was noted.Another resolute onyx device was used to complete the procedure.No patient complications reported for this event.

Manufacturer Narrative

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

Manufacturer Narrative

Product analysis summary: there were two kinks on the catheter 22.2cm and 51.2cm distal to the strain relief.The stent was positioned on the balloon between the marker bands as per specifications.No deformation was evident to the stent wraps.Deformation was evident to the distal tip.The 0.015 mandrel would not load through the guidewire lumen due to hardened blood in the catheter.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: 7680912
• MDR Text Key: 114420630
• Report Number: 9612164-2018-01701
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2020
• Device Model Number: RONYX30022X
• Device Lot Number: 0008958290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2018
• 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