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

Model Number	RONYX30022UX
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/22/2021
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
During a procedure an attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a mildly tortuous and none calcified lesion in the proximal-mid rca with 99% stenosis.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that stent deformation occurred in vivo post deployment.The stent was post-dilated to 3.5mm at high pressure with no issues.Post cine imaging showed a possible stent fracture in the mid stent.A non medtronic stent was deployed over the fractured section of deployed resolute onyx and post dilated to 3.5mm.The patient is reported as alive with no injury.
Additional Manufacturer Narrative
Additional information: cine images were received as video recordings of a pc screen.Image quality was poor making it difficult to clearly identify issues.It is not possible to determine if the videos received were in chronological order of procedure.A review of the cine images received showed a stent being deployed in the rca.Later images showed deformation to the deployed stent however it is difficult to determine if the deformation identified was a stent fracture.Annex d codes added.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: there were no previously deployed stents at the site of treatment.There were no difficulties during stent deployment.The balloon of the device successfully deflated post stent deployment.The balloon used for post dilatation balloon 3.5 x 15 mm.There were two attempts of inflation with the post dilation balloon, one attempt at 11atm and the second attempt at 15atm.There were no difficulties noted during the removal of the guidewire.The balloon or delivery system did not snag on the deployed stent.It was reported that the fracture site was covered with a 3.0 x 12mm non-medtronic stent which was post dilated with a 3.5 x 15mm non compliant balloon inflated twice at 15 atms max.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 provided show severe stenosis in the proximal to mid right coronary artery.The lesion is pre-dilated and a resolute onyx device appears to be deployed.The profile of the stent in vivo shows possible deformation which is highlighted in the image review.A second stent is seen to be deployed inside of the resolute onyx and post dilation is observed after this implantation.The final image shows improved blood flow through the rca.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
• MDR Report Key: 12065341
• Report Number: 9612164-2021-02482
• Device Sequence Number: 20021544
• Product Code: NIQ
• UDI-Device Identifier: 00643169557000
• UDI-Public: 00643169557000
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 08/25/2021

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: 03/04/2023
• Device Model Number: RONYX30022UX
• Device Catalogue Number: RONYX30022UX
• Device Lot Number: 0010587875
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 06/25/2021; 08/10/2021; 08/19/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 07/12/2021; 08/18/2021; 08/25/2021
• 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: 74 YR
• Patient Weight: 58