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

Model Number	RONYX22526UX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Injury (2348); Insufficient Information (4580)
Date of Event	10/06/2020
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
During a procedure an attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a lesion located in the right coronary artery (rca).The device was inspected with no issues noted.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.The device was not kinked or re-straightened during use.It was reported that the device detached at the catheter during delivery through the vessel.The detached portion of the stent catheter was removed safely by trapping it with a coronary balloon inside a turnpike guide extension catheter and removing from the patient.The patient was reported to be alive with no further injury.
Additional Manufacturer Narrative
Product analysis noted no detachment on the delivery system.The stent was positioned between the markerbands as per specification.No stent deformation was noted.No deformation was noted 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.Additional information a nc euphora rx balloon catheter returned along side the resolute onyx with a detachment on the hypertube.During analysis, it was noted that a kink was identified on both sides of the hypertube.The balloon folds were expanded and blood was visible in the balloon.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
Procedural images provided confirmed that the patient previously underwent coronary artery by-pass (cabg) and that the proximal to distal rca contained a jacket of stents.There was a degree of in-stent restenosis in the proximal rca.The rca was pre-dilated and the delivery wire and support wire were present in the vessel, confirming the difficulty nature of the delivery of devices tot he distal vessel.The target lesion was determined to be in the distal rca.A stent was delivered but was not deployed and it was removed from the vessel with the assistance of a guide extension catheter (gec).After further ballooning and use of an atherectomy devices to widen the lumen stents were deployed successfully.The vessel and target lesion morphology appears to have impacted on the events.Patient gender added to a3 correction: device catalog # and lot details 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: 10688790
• Report Number: 9612164-2020-03951
• Device Sequence Number: 19653753
• Product Code: NIQ
• UDI-Device Identifier: 00643169556744
• UDI-Public: 00643169556744
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: 10/30/2021
• Device Model Number: RONYX22526UX
• Device Catalogue Number: RONYX22530UX
• Device Lot Number: 0009993884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 12/01/2020; 01/28/2021
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 12/14/2020; 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