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

Model Number RONYX22538X

Device Problems Difficult to Insert (1316); Material Deformation (2976); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2023

Event Type  malfunction  

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.

Event Description

An attempt was made to use one 2.25x38mm resolute onyx rx coronary drug-eluting stent (des) to treat a lesion in the distal obtuse marginal (om) and left circumflex (lcx) artery. the device was not inspected.Negative prep was not performed. the lesion was pre-dilated with a 2.0x15mm sprinter balloon at 16 atm.Resistance was encountered when advancing the device.Excessive force was not used during the delivery.It was reported that the stent failed to cross/positioned the lesion and the stent was deformed.It was detailed that a non-medtronic wire was secured in distal om1.Following pre-dilation, resistance was noted when advancing the 2.25x38mm resolute onyx stent.When the stent was removed it was noted to be deformed.The deformed stent was exchanged for another 2.5x30mm stent deployed at 12atm followed by another 3.0x30mm resolute onyx stent deployed at 14 atm.Post-dilatation was done using a 3.0x15mm nc euphora balloon.A very good final result was achieved with timi iii flow.It was detailed that a percutaneous coronary intervention (pci) to the left anterior descending (lad) was also done.A xb3.5 guide catheter was used to engage the left marginal (lm) coronary artery and a non-medtronic guidewire was secured in the distal lad.The lesion was pre-dilated using a 2.0x15mm sprinter balloon inflated several times up at 16atm.The lad was stented using a 2.5x48mm non-medtronic stent deployed at 10atm.Post-dilatation was done using a 3.0x15mm nc euphora balloon inflated several times up to 20atm.A very good final result was achieved with timi iii flow.The pci to lad with one des and lcx-om1 with two des were successful.The patient is alive with no injury.

Manufacturer Narrative

Image analysis: two images were received from the account.The first image shows mid and distal stent deformation with struts raised.The second image shows the sterile label of a ronyx22538x, lot number 0011352787, which matches what was reported on file.Additional information: the lesions were pre-dilated with a 2.0x15mm sprinter legend balloon at 16 atm.There were no issues during use of the sprinter legend device.The 2.5x30mm stent deployed at 12 atm in the lcx-om1 was a non-medtronic device.Facility address.Correction: patient initials.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

Additional information: the same 2.0x15mm sprinter legend balloon was used to pre-dilate both lesions, the lcx-om1 and lad.There was no complaint against any other medtronic device used during the procedures.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 ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17876576
• MDR Text Key: 324987274
• Report Number: 9612164-2023-04506
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX22538X
• Device Catalogue Number: RONYX22538X
• Device Lot Number: 0011352787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Date Device Manufactured: 08/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female