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

Model Number RONYX45018X

Device Problems Burst Container or Vessel (1074); Material Puncture/Hole (1504)

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

Event Date 07/17/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A resolute onyx was intended to be used during a procedure.The intended lesion was located in the mid rca, and had moderate tortuosity and mild calcification.No damage was noted to packaging and no issues were noted when removing the device from the hoop.The device was inspected and negative prep performed with issue.The lesion was not pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device, and excessive force was not used during delivery.It is reported that the stent was prepped for implant and the balloon burst on the first inflation during stent deployment.12 atms of pressure had been applied.It is noted that the balloon did not inflate to the nominal value.The system was withdrawn and the balloon was inflated post stent deployment to find a small hole in the balloon material.An nc balloon was used to post-dilate the stent.No patient injury is reported.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: the balloon returned with blood visible in the balloon and inflation lumen.The balloon failed negative prep.On pressurisation of the delivery system, water was observed exiting the guidewire entry port.The balloon failed to maintain pressure.The balloon material was cut to expose the guidewire lumen.Upon visual inspection a puncture site was observed proximal to the distal marker band.The material at the puncture site was protruding outwards, the material at the puncture site felt jagged and uneven when touched.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: when the device was being prepped for use it was noticed that there was fluid in the balloon of the stent.The stent was deployed, the physician was concerned that the nominal rate was not achieved and post dilated with a nc balloon.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: 7721568
• MDR Text Key: 115354938
• Report Number: 9612164-2018-01860
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2019
• Device Model Number: RONYX45018X
• Device Catalogue Number: RONYX45018X
• Device Lot Number: 0008862273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2017
• 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