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

Model Number	RONYX20018UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Insufficient Information (4580)
Date of Event	10/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A 2.0 x 18 mm resolute onyx coronary drug eluting stent was attempted to be used to treat a moderately tortuous, moderately calcified lesion in the mid-distal rca.The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated.The device did pass through a previously deployed stent.Resistance was not encountered when advancing the device and excessive force was not used.Prior to attempting the 2.0 x 18 mm device, a 2.75 mm resolute onyx was deployed in the proximal vessel and another 2.75 mm resolute onyx was deployed distal.It was stated that these stents were post-dilated and not under-deployed in any manner.A third 2.75 mm resolute onyx was also attempted but failed to cross.The lesion was ballooned again.It was reported that the 2.0 x18 mm stent dislodged during delivery to the lesion.An attempt was made to remove the stent but was u nsuccessful.The patient was sent to surgery to remove the dislodged stent and to treat the mid-distal lesion.No further patient injury reported.
Additional Manufacturer Narrative
Additional information: the device was prepped per ifu with no issues.This third 2.75 mm resolute onyx device was inspected before use with no issues noted.Resistance was noted while advancing the device to the lesion but excessive force was not used.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.
Additional Manufacturer Narrative
Additional information: procedural images were provided for review.The images show a moderately tortuous, moderately calcified lesion in the mid-distal rca.Pre-dilation of the lesion can be seen along with the deployment of multiple stents.Post-dilation of the stents is evident.However, the images do not show the failure to deliver a stent or the dislodgement of another stent.The dislodged stent appears to be present at the distal end of the previously deployed proximal stent.The dislodge stent was not removed from the vessel during pci despite attempts.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: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10689183
• Report Number: 9612164-2020-03963
• Device Sequence Number: 19653754
• Product Code: NIQ
• UDI-Device Identifier: 00643169556652
• UDI-Public: 00643169556652
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: RONYX20018UX
• Device Catalogue Number: RONYX20018UX
• Device Lot Number: 0010158045
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 10/16/2020; 01/29/2021
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 11/02/2020; 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR