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

Model Number	RONYX40038UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
One 6f telescope guide extension catheter (gec) and one 4.0x38mm resolute onyx coronary drug eluting stent were attempted to be used to treat a severely tortuous, severely calcified lesion with 99% stenosis in the mid right coronary artery (rca).There was no damage noted to the device packaging.The devices were removed from the packaging per ifu.The devices were inspected prior to use with no issues noted.The telescope was prepped with no issues noted.Negative prep was not performed on the resolute onyx device.The lesion was pre-dilated.The devices did not pass through a previously deployed stent.Resistance was not encountered when advancing the telescope and excessive force was not used.Resistance was encountered when advancing the resolute onyx, excessive force was not used.  the resolute onyx stent was attempted to be delivered to the lesion but it failed to cross so was removed from the patient.The telescope device was then advanced and further pre-dilation was performed at the lesion.The resolute onyx was advanced again but this time would not advance through the entry port of the telescope.It was reported that the loading ramp of the telescope was noted to be peeled off the shaft, and this is what was preventing the stent from passing through the telescope.It was also reported that stent deformation occurred in vivo during advancement.The telescope device was removed.A new telescope was advanced down the rca and a new 4.0x38mm resolute onyx stent was delivered to the lesion.No patient injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary: the device returned for evaluation.A kink was evident on the hypotube.The stent was positioned on the balloon between the marker bands as per position specification, but due to distal stent deformation the stent did not meet visual acceptance specification.Deformation was evident to the distal stent wraps with struts bunched and overlapping.Deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.No other damage evident to the remainder of the device.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14218836
• Report Number: 9612164-2022-01610
• Device Sequence Number: 17192127
• Product Code: NIQ
• UDI-Device Identifier: 00643169557222
• UDI-Public: 00643169557222
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/22/2024
• Device Model Number: RONYX40038UX
• Device Catalogue Number: RONYX40038UX
• Device Lot Number: 0010950986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 99 KG