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

Catalog Number RONYX25015X

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)

Patient Problem Injury (2348)

Event Date 10/09/2019

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 lesion.The device was inspected with no issues noted.Negative prep was not performed.It was reported that the stent balloon burst during stent deployment.As the stent was not expanded enough it could not be removed, therefore another balloon was used to deploy the stent successfully.The patient was reported to be alive with no further injury.

Manufacturer Narrative

The lesion was without excessive calcification.The lesion was pre-dilated with a 2.0x12mm non-medtronic balloon.The resolute onyx was placed on a non-medtronic guidewire and delivered at once to the pre-dilated lesion.No excessive force was used during delivery.The stent was inflated to 14 atm, it was reported that is was not possible to hold the pressure in the stent balloon and that the pressure drooped gradually.The stent was post-dilated with a non-compliant balloon without further complications.The device was not moved or repositioned in the lesion prior to the burst.A very small hole was noted in the apex of the stent balloon when it was removed from the patient.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation summary: a kink was evident on the hypotube.The device returned with blood visible in the balloon.The balloon failed negative prep.On pressurisation of the device, liquid was observed exiting the balloon proximal cone.The balloon failed to maintain pressure.Upon visual inspection of the delivery system, there was a burst site on the balloon material immediately distal to the proximal marker band.There was no other damage evident to the remainder of the delivery system.Additional information: the patient was a acs patient without excess calcification in the coronary arteries.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: 9192408
• MDR Text Key: 162689684
• Report Number: 9612164-2019-04369
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2021
• Device Catalogue Number: RONYX25015X
• Device Lot Number: 0009909021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 10/15/2019; 11/21/2019
• Supplement Dates FDA Received: 11/13/2019; 12/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2019
• 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