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

Catalog Number RONYX20030UX

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problems Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Date 11/28/2022

Event Type  Injury  

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 resolute onyx drug eluting stent to treat a non tortuous, moderately calcified lesion with 85% stenosis in the distal right coronary artery (rca).The device was inspected with issues.The lesion was pre-dilated using a non compliant balloon., 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 dislodgement occurred during removal following failed delivery.It was stated that when the stent was inserted into the patient it delivered easily however it was decided to prep the vessel some more.When trying to pull the stent back for removal the stent sheered off the balloon and dislodged into the vessel.It did not feel like any excessive resistance was used when pulling back the device.If resistance was encountered it was stated that the health care professional would have stopped.When the delivery system was removed from the guide catheter shock was expressed when it was realized that the stent was left behind in the right coronary artery (rca) and how little force it took to make the stent sheer off the balloon.It was stated that it is possible that if the vessel started to spasm that this would cause the stent to sheer off or maybe it was just easy for the stent to be sheered off.  it was detailed that wires were inserted pas the stent however it was only possible to get a 1.0mm balloon past the stent.The dislodged stent was left in the right coronary artery (rca).No patient complications or clinical problems were experienced.The patient is reported to be doing well and has the same level of occlusion in the vessel.

Manufacturer Narrative

Additional information: the device was inspected with no issues noted.As only the wire and a 1.0 mm balloon were able to be advanced past the stent it was not possible to fully crush it up against the vessel wall as was hoped.Although the stent is not fully crushed up against the wall, it is reported to be in a stable location.It was later confirmed that it is believed that the stent that is now left inside the vessel is causing the occlusion.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

Correction: it was intended to crush the dislodged stent against the vessel wall.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: there was difficulty experienced when crossing the lesion.When trying to pull the stent back for removal from the proximal rca the stent sheared off the balloon and dislodged into the vessel.It was stated that the stent got stuck on the lesion which was being attempted to cross.Multiple attempts were made to cross the lesion with a balloon and inflate the stent further however that was not possible.No patient complications or clinical problems were experienced.Image review: two still fluoroscopic images were provided for review to support the root cause investigation.No images were provided showing the target lesion in the distal rca or the movement of stent and delivery system during removal post the unsuccessful delivery.The images provided show the presence of the dislodge stent in the proximal rca.The short balloon that was used during retrieval and crushing attempts can be seen in one of the images exiting or being pulled back into the guide catheter.Although there appears to be a heavy calcium burden in the mid to distal vessel with a previously deployed stent being evident in the distal vessel.The impact of the vessel morphology or previously deployed stent, or procedural accessories cannot be confirmed that have impacted on the stent dislodgement.Correction: ime code 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: CORONARY DRUG-ELUTING STENT
• 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: 15914541
• MDR Text Key: 304786461
• Report Number: 9612164-2022-04573
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/20/2023

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 Catalogue Number: RONYX20030UX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 12/01/2022; 12/06/2022; 12/22/2022
• Supplement Dates FDA Received: 12/05/2022; 12/19/2022; 01/20/2023
• 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 Outcome(s): Required Intervention
• Patient Sex: Male