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

Model Number RONYX27518UX

Device Problems Migration or Expulsion of Device (1395); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Non specific EKG/ECG Changes (1817); Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 03/09/2022

Event Type  Injury  

Event Description

Two resolute onyx coronary drug eluting stents were implanted to treat a non-tortuous lesion in the mid right coronary artery (rca).The devices were inspected with no issues noted.The mid-distal rca was pre-dilated with a semi compliant balloon.The devices did not pass through a previously deployed stent.Resistance was not encountered when advancing the devices and excessive force was not used during delivery.  it was reported that the first stent was deployed and then migrated to the proximal rca.The migrated stent was then post-dilated and secured using an nc balloon.The second stent was deployed in the original lesion site but this stent also migrated, distally.Both stents were secured after successive nc dilation.A third resolute onyx stent was then placed between the first two stents.No further patient injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: it was suggested that the operator undersized the stents leading to the migrations.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 lesion had 80% stenosis.There was timi 2 flow pre-procedure.There was mild diffuse disease of the right posterolateral artery (rpl) and the right posterior descending artery (rpda).The lesion was engaged with a jr4 guide catheter and a non-mdr guidewire was advanced to the lesion.The mid-distal rca was pre-dilated with a 2.5 x 12 mm semi compliant balloon.The first stent (pli10) was deployed at nominal pressures and then migrated to the proximal rca.When the stent delivery system was removed it was noticed that the stent had come off the delivery system and was not deployed in the desired mid segment and instead had migrated to the proximal segment of the vessel.The second stent (pli20) was deployed in the original mid lesion site at nominal pressures.A third resolute onyx stent (pli30) was then placed between in over lapping fashion with the previous stent.Cine images following stent deployment showed that the previous stent (pli20) had migrated distally.An 2.75 mm balloon was advanced and was able to pull back the stent to the mid segment where it was deployed at high pressures.The same 2.75mm balloon was then used to to push the proximal stent (pli10) to the mid segment, which was then deployed and post-dilated.There was then excellent stent apposition and expansion with timi 3 flow post pci.Repeated cine images showed stable stent position and no further migration.The diseased segment was covered and although the stents were not completely overlapping the intermediate segment between the stents had no significant lesion and no further attempts were made to overlap with another stent.The patient had significant spasm during the procedure and was given 2.5 mg of versed and 125mg of fentanyl along with 4000mcg nitroglycerin.Correction: annex a 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.

Manufacturer Narrative

Additional information: the right radial artery was used as access.A j wire was inserted followed by a medtronic dexterity diagnostic catheter.Right coronary artery angiogram and left coronary artery angiogram were performed in multiple views using the dexterity.The dexterity catheter was then removed over the wire.The images were reviewed and the decision was made to proceed with intervention of the rca.The mid-distal rca was pre-dilated with a 2.5x12 mm euphora semi complaint balloon at 12 atm for 10 seconds, followed by 12 atm for 5 seconds.The devices did not pass through a previously deployed stent.The first stent (pli10 - 2.75x18mm) was advanced across the rca lesion and deployed at 12 atm for 5 seconds.The migrated stent was post-dilated and secured using a 3.25x12mm nc euphora balloon catheter at 8 atm for 12 seconds, and at 16 atm for 6 seconds.The second resolute onyx stent (pli20 - 2.75x18mm) was deployed in the original mid lesion site at 12 atm for 7 seconds and was re-inflated at 12 atm for 12 seconds.St elevation was noted.A 2.75x15mm nc euphora balloon catheter was advanced and was able to pull back the stent to the mid segment where it was deployed at 16 atm for 14 seconds and 16 atm for 10 seconds.A fourth resolute onyx stent (2.75x8mm - pli40) was advanced across the rca lesion and deployed at 16 atm for 20 seconds.A fifth resolute onyx stent (2.75x12mm - pli50) was inserted and advanced but was removed as it failed to cross the lesion.The 2.75x15mm nc euphora was inserted and inflated to 16 atm for 10 seconds and 16 atm for 7 seconds.Balloon catheter, guidewire and guide were removed.Procedural images were provided for review.The images confirm the presence of the target lesion in the mid-rca.There is no evidence of calcification or tortuosity in the rca.Images showing the delivery and deployment of the medtronic stents were not provided.The images confirm that the first stent appeared to migrate from the mid vessel to the proximal vessel, as an expanded stent is visible in the ostium/to proximal rca.The second stent was shown to be expanded in the mid vessel but subsequent images show that it has migrated distally.The mechanism of migration for both stent was not shown on the images.Subsequent images show the movement of the second stent back towards the mid vessel, but it was not positioned as proximal as where it was originally deployed.The proximal stent was also re-positioned towards the mid vessel lesion.There was a gap between the stent post re-positioning and they did not overlap, as described in the event description.There was no root cause for the stent migration evident from the two-dimensional (2d) procedural images.The possibility exists that the deployment pressures may not have been sufficient to fully appose the stents to the vessel wall.But this cannot be confirmed from the images.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

Product analysis summary: the stent was not present on the balloon and did not return for analysis.Crimp impressions were visible on the exposed balloon surface.The balloon folds were fully expanded.The balloon was inflated to a nominal of 12 atm to measure the outer diameter of the balloon working length when inflated.The inner lumen was verified with a 0.015 inch mandrel.No other damage evident to the remainder of the device.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: 13840063
• MDR Text Key: 287545271
• Report Number: 9612164-2022-01091
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556904
• UDI-Public: 00643169556904
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2023
• Device Model Number: RONYX27518UX
• Device Catalogue Number: RONYX27518UX
• Device Lot Number: 0010601582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2021
• 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 Age: 63 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White