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

Model Number	RONYX20015UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Myocardial Infarction (1969)
Date of Event	01/15/2021
Type of Reportable Event	Death
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 two resolute onyx rx coronary drug eluting stents to treat a severely tortuous and severely calcified lesion in the mid/proximal rca.It was noted that the lesion was very small and diffuse and was completely occluded (100%).The patient presented with cardiac arrest and was intubated in the cath lab.The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated with a sc balloon.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device and excessive force was not used.An attempt was made to use a 2.50 x 18 mm resolute onyx however the device failed to cross the lesion.A resolute onyx 2.00 x 15 mm was then attempted to be used however stent dislodgement occurred during removal following failed delivery.The stent was removed in order to reposition and it was noted that the stent was not on the catheter.Another wire and a non medtronic balloon was used and the stent was deployed.The procedure was completed using two additional resolute onyx's devices, one was deployed in the proximal rca and the other was deployed in-between the previously deployed stents.The patient died one day post procedure from cardiogenic shock due to inferior stemi and cardiac arrest.The physician stated that the device failure led to failure of intervention.This patient had very high predicted mortality regardless but device failure led to further deterioration.
Additional Manufacturer Narrative
Additional information: it was later stated that the patient was stable with an ef of 55% and although complications in the pci procedure, the cause of death was due to cns and inhibited brain activity.As the patient was down due to out of hospital cardiac arrest for 40 mins, the cause of death was not cardiac related due to the procedure.It was further stated that because the lesion was very tortuous and calcified, the physician did not advance with a balloon to pre-dilate and that was when the 2.00 x 15 onyx stent was stripped off.The physician didn't believe the device related issues contributed to the patients death.Non medtronic balloon size: 2.50mm 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
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
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11265308
• Report Number: 9612164-2021-00442
• Device Sequence Number: 1219202
• Product Code: NIQ
• UDI-Device Identifier: 00643169556645
• UDI-Public: 00643169556645
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 03/25/2021

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: 08/19/2022
• Device Model Number: RONYX20015UX
• Device Catalogue Number: RONYX20015UX
• Device Lot Number: 0010342738
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 02/04/2021; 03/23/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/01/2021; 03/25/2021
• 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: Death; Required Intervention
• Patient Age: 78 YR