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

Model Number RONYX40038UX

Device Problems Difficult to Remove (1528); Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis summary: a resolute onyx (4.0 x 38), was returned loaded in a telescope (6f) gec.The stent was positioned on the balloon, but not meeting specifications, the stent had moved distally on the balloon, over the distal markerband.Crimp impressions were evident on the exposed balloon surface.Deformation was evident to the distal stent wrap, which had become entangled in the exposed coil of the telescope gec.The deformed stent struts appeared raised.No deformation was evident to the distal tip.The inner lumen could not be verified with a 0.015 inch mandrel, most likely due to hardened blood in the guidewire lumen.Difficulty was encountered when attempting to separate the resolute onyx from the telescope gec, due to the deformation of both devices.In order to separate the devices, the proximal shaft of the resolute onyx was cut, and the device was pulled distally.Slight bends are evident on the shaft of the device which are consistent with coiling of the device for return.No other deformation was evident to the device.Correction: three images received: an image shows three devices in a bio-hazard bag; two 6f telescope devices and a resolute onyx stent delivery system.An image is blurred but appears to show a stent loaded in a telescope device.An image is blurred but shows the distal end of a telescope device.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.

Event Description

A 6f telescope guide extension catheter and a 4.0 x 38 mm resolute onyx were being used during a procedure to treat a mildly tortuous, moderately calcified lesion exhibiting 70% stenosis in the ostium and proximal of the left main (lm) coronary artery and left anterior descending (lad) artery.There was no damage noted to the packaging of the telesope device.The telescope was removed from the hoop as per ifu with no issues.Both the telescope and resolute onyx stent were inspected with no issues.The telescope was prepped as per ifu with no issues.The lesion was not predilated.Resistance was not encountered when advancing the telescope or resolute onyx devices.Excessive force was not used during delivery of the telescope or resolute onyx device.The first telescope device was used to secure access to the left main artery while implanting the corevalve device.A second telescope device and a stent were used to protect the right coronary.There were no issues with the second telescope device used to protect the right coronary artery.There was an old surgical non-medtronic valve and a previously deployed corevalve that were already implanted in the past.Both of those valves had failed and another, new corevalve was intended to be implanted during this procedure.The first telescope and the 4.0 x 38mm resolute onyx stent were positioned in the lm artery before deploying the corevalve.Once placed, the corevalve was successfully deployed and the valve was post dilated, while the telescope was on the side of the valve.The resolute onyx stent did not have to be deployed because the lm ostium was not compromised by the new valve frame.It was reported that upon removal, the resolute onyx was noted to be deformed and stuck in the first telescope device.The telescope was also noted to be stuck in between two corevalves and was unable to be withdrawn.The telescope device was excessively torqued.There was no guidewire still in situ while the telescope was being torqued.It was reported that the telescope device was pulled back using excessive force and efforts as the tip was jammed, the telescope released, but only after the distal 2mm purple tip detached off the telescope catheter.It was determined that 2mm of the telescope tip was missing by comparing the tip to a non damaged telescope on removal.The tip was left sandwiched between the corevalve frames, as it was completely stuck.The tip remains there and no intervention was performed to attempt to remove the tip section.The procedure was completed without patient injury.It was reported that stents were positioned in the arteries before deploying the corevalve in case the corevalve jailed (blocked) the ostium of the rca and lm.When the corevalve didn¿t block the arteries after deployment, the stents were removed undeployed from the lm and rca arteries.The stent from the rca was removed without issue.The lm resolute onyx stent was stuck in the telescope device.A 6fr launcher guide catheter and non-medtronic wire were used during the procedure.The second telescope device, used to protect the right coronary artery returned for analysis.It was reported deformation occurred to this telescope device during packaging the device for return.The physician assessed that the event was not a product issue but was related to the patient and the procedure.

Manufacturer Narrative

Additional information: the first telescope device was used to secure access to the left main artery while implanting a medtronic evolut transcatheter aortic valve replacement device (tavr).The left coronary artery was a protected left main prior to implantation.A new corevalve, medtronic evolut tavr device was intended to be implanted during this procedure.It was stated that the telescope lost tactile feedback after the removal of the stent and the wire.Some resistance was felt at the time of the tip fracture while removing the equipment.The tip was left sandwiched between the corevalve frames, the aorta and the evolut tavr device as it was completely stuck.The procedure was completed without patient injury and no further complications noted.It was stated that the telescopes were used as the initial case plan.This was a protected left main case with transcatheter aortic valve implantation (tavi) and is a commonly used method so it is not clear the precise reasons for the tip fracture.No other devices contributed to this event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 9465045
• MDR Text Key: 188146494
• Report Number: 9612164-2019-05150
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557222
• UDI-Public: 00643169557222
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Model Number: RONYX40038UX
• Device Catalogue Number: RONYX40038UX
• Device Lot Number: 0009945471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2019
• 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