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

Model Number RONYX27534UX

Device Problems Burst Container or Vessel (1074); Inflation Problem (1310); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 05/02/2022

Event Type  Injury  

Event Description

An attempt was made to use a resolute onyx 2.75 x 34mm coronary drug eluting stent to treat a mildly tortuous, severely calcified lesion in the distal right coronary artery (rca).The device was inspected with no issues.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was used during delivery.It was reported that inflation difficulties occurred.Difficulty was encountered with deliverability to the distal right coronary artery.The sequence of the procedure is as follows.A 6f guide catheter was introduced, advanced, and removed.A 0.014x180cm run-through guidewire was advanced across the right coronary artery (rca) lesion.An ivus catheter was advanced into the distal (rca) lesion and images were obtained, the catheter was then removed.A 2.5x12mm non-mdt non-compliant balloon was inflated at 15 atm for 10 seconds across the distal right coronary artery (rca).This was repeated three times.The balloon was re-inflated at 20 atm for 10 seconds and 26 atm for 10 seconds across the mid right coronary (rca) lesion.The balloon was removed.The 2.75x34mm resolute onyx rx device was prepped, was observed on the balloon, and the stylet was removed.The stent was advanced and inflation difficulties were encountered.It was not possible to inflate the stent.The stopcock connection was checked and re inflation was attempted however the stent would not expand.An attempt was made to use a syringe to expand the stent however with no success.Upon attempting to retrieve the partially expanded stent it engaged with the catheter tip and forced the stent to be expanded in the ostium of the proximal right coronary artery (rca).The stent was post dilated to ensure apposition.Another stent was deployed through the ostial stent and advanced to fix distal stenosis.The second stent was successfully deployed with no issues.A 2.0x12mm euphora balloon was prepped, advanced, and inflated to 10 atm for 10 seconds across the proximal right coronary (rca).The balloon was then removed.A 2.0x10mm euphora balloon was prepped, advanced, and inflated to 18 atm for 10 seconds across the proximal right coronary artery (rca) lesion.This was repeated twice.The balloon was reinflated across the proximal right coronary artery (rca) at 20 atm for 10 seconds.The balloon was then removed.A 3.0x10mm euphora balloon was prepped, advanced, and inflated to 20 atm for 10 seconds.The balloon was re-inflated to 18 atm for 10 seconds across the proximal right coronary (rca) lesion.This was repeated 3 times.The balloon was then removed.A 5.0x08mm euphora non-compliant balloon was prepped, advanced and inflated to 5 atm for 10 seconds across the proximal right coronary artery (rca).The balloon was then removed.A 0.014x180cm non-mdt guidewire was advanced across the right coronary artery (rca) lesion.A 4.0x10mm euphora balloon was prepped and advanced across the proximal right coronary artery (rca).The device was inflated to 12 atm for 10 seconds.The device was re-inflated to 18 atm for 10 seconds and re-inflated again to 20 atm for 10 sections.This was repeated twice.The device was then removed.A 2.75x34mm resolute onyx rx stent was deployed.The run-through wire was removed.A 6f non-mdt guide catheter was introduced into the sheath and advanced.The wire was removed.A 2.75x30mm resolute onyx stent was prepped, was observed on the balloon, and the stylet was removed.The stent was advanced across the distal right coronary artery (rca) and deployed sucessfully at 12 atm for 10 seconds at the distal (rca).The stent balloon was re-inflated at 12 atm for 10 seconds across the mid right coronary artery (rca)and re-inflated again to 18 atm for 10 seconds across the mid right coronary artery (rca).This was repeated 3 times.The stent balloon was removed.A 3.5x38mm resolute onyx stent was prepped, was observed on the balloon, and the stylet was removed.The stent was adv anced and deployed at 14 atm for 10 seconds in the mid right coronary artery (rca) lesion.The stent balloon was re-inflated at 12 atm for 10 sec and then removed.A 5.0x08mm euphora non-complaint balloon was prepped and re-advanced across the proximal right coronary artery (rca) and inflated to 20 atm for 10 seconds, 15 atm for 20 seconds and 20 atm for 10 seconds.The balloon was then removed.A 3.0x12mm euphora non-complaint balloon was prepped and advanced across the distal right coronary artery (rca) at 14 atm for 10 seconds, 20 atm for 10 seconds and re-inflated across the mid right coronary (rca) lesion at 20 atm for 10 seconds.This was repeated twice.The balloon was then removed.An ivus catheter was prepped and readvanced into the distal right coronary artery (rca) and images were obtained.The ivus catheter was then removed.All interventional equipment was removed from the patients body intact.It was reported that there was no harm to the patient.After retrieving the catheter a flush test was performed.It was noted that saline was escaping from two pin holes a few cm proximal to the proximal balloon marker band.This is what is believed to have contributed to the resolute onyx 2.75 x 34mm balloon not expanding in body since contrast would have been escaping through pin hole thereby reducing pressure and atmospheres.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: there was partial inflation of the balloon and the stent was partially expanded.The stent dislodged when the resolute onyx device engaged with the catheter tip.The stent was not sufficiently expanding prior to attempting removal of the balloon.There is no complaint against any other medtronic devices used.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: a number of still fluoroscopy images of the rca were received for review.The event reported that the complaint device did not pass through a previously deployed stent, but all images provided appear to have a short stent deployed in the proximal ostial rca.There appears to be diffuse calcified disease present throughout the vessel, with a stenotic lesion in the mid-rca.Based on the vessel disease the possibility exists that the balloon of the device was damaged during delivery but there are no images showing the attempted delivery and pressurization of the stent for deployment.Annex d code added correction: annex g code added intervention required ticked.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

Device evaluation summary: device was returned for evaluation.A kink was evident on the hypotube.The device returned with balloon folds partially expanded.Blood was visible in the balloon.No evidence of necking on the balloon bond.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 failed negative prep.An attempt was made to inflate the balloon to 12atm, but the balloon could not maintain pressure.On pressurisation of the device, liquid was observed exiting the distal shaft of the device.Upon visual inspection of the device, two pin hole tears were observed on the distal shaft.A lead in scratch was evident at the leak site.No other deformation evident to the remainder of the device.Annex b, annex c, annex d codes 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.

• 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: 14560006
• MDR Text Key: 293070488
• Report Number: 9612164-2022-02074
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556942
• UDI-Public: 00643169556942
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX27534UX
• Device Catalogue Number: RONYX27534UX
• Device Lot Number: 0010706055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2021
• 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: 68 YR
• Patient Sex: Female