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

Model Number RONYX22518UX

Device Problems Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problems Death (1802); Occlusion (1984)

Event Date 09/01/2020

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A resolute onyx des was used during a procedure to treat a acute mi/nstemi multi vessel disease.The lesion was 100% occlusion and was unable to be crossed.They proceeded with intervention of the l circumflex artery.This was difficult to cross due to the angulation.The balloon did manage to cross this lesion.The onyx stent was advanced but would not cross the lesion.It was reported that when they pulled back the stent due to the occlusion of the circumflex artery the stent dislodged off the balloon.An attempt was made to retrieve the stent but this appeared to interrupt the flow of the lad artery.The patient was unstable.They proceed with the pci to the lad.The stent was successfully delivered in the lad.The l circumflex artery remained occluded.Multiple attempts were made but not successful.Patient had re-occurring vfib, acls/cpr measures were unsuccessful.The patient died.

Manufacturer Narrative

Additional information: an attempt was made to retrieve the stent but the stent would not retract and this appeared to interrupt the flow of the lad artery.Multiple attempts were made with different wires but not successful.Surgery was consulted.Patient worsened.Repeat angiography obtained showed occlusion of lad stent site so a repeat ptca was performed.Correction: intervention of the right coronary artery was planned but the lesion had 100% occlusion and was unable to be crossed.Intervention required ticked implant date added initial reporter occupation sent to fda - yes selected other report source 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.

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.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
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10585071
• MDR Text Key: 208481811
• Report Number: 9612164-2020-03612
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556720
• UDI-Public: 00643169556720
• Combination Product (y/n): N
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2022
• Device Model Number: RONYX22518UX
• Device Catalogue Number: RONYX22518UX
• Device Lot Number: 0010190154
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 10/01/2020; 10/30/2020
• Supplement Dates FDA Received: 10/23/2020; 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention