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

Model Number RONYX30015X

Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Material Deformation (2976); Positioning Problem (3009)

Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Date 12/26/2023

Event Type  Injury  

Event Description

The patient presented with non-st-elevation myocardial infarction (nstemi) and chest pain.A coronary computed tomography angiography (ccta) suggested distal rca stenosis.An attempt was made to use one resolute onyx drug eluting stent to treat a lesion in the distal right coronary artery (rca) bifurcation.A right radial approach was used.It was reported that stent dislodgment occurred following a failed delivery.It was detailed that an attempt was made to place the stent in the right posterior descending artery (rpda) however, the stent would not advance.When the stent was being removed, it dislodged from the balloon in the mid rca.A nc balloon was used to compress the stent to the rca wall.Intravascular ultrasound (ivus) showed mal apposition which was post dilated at 4.5mm to give a good ivus result.The pda was stented.The distal rca was post dilated with a 3.5mm nc balloon using the proximal optimization technique (pot).The patient went on dual antiplatelet therapy (dapt) (aspirin (asa) and ticagrelor for 1 year, then plavix for life).No further patient injury was reported.

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.

Manufacturer Narrative

Image review: two still fluoroscopic images were provided for review.The first confirms the presence of a dislodged stent in the mid right coronary artery (rca).The second image shows contrast injection into the rca.This confirms a severely tortuous bend in the proximal rca.This suggests that during stent withdrawal the stent came off the delivery system during attempts to pass through the tortuous proximal bend.Additional information: the device was inspected before use with no issues noted.The device was prepped per ifu with no issues noted.Negative pressure was not done.The lesion was pre-dilated.The device did not pass through a previously deployed stent.A non-medtronic nc balloon was used to compress the stent to the rca wall.A second stent was implanted to keep the stent fully expanded to the side of the vessel.The pda was stented with a resolute onyx stent with no issues noted.The distal rca was post dilated with a 3.5mm non-medtronic nc balloon using the proximal optimization technique (pot).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 resolute onyx stent was malapposed before being compressed by the nc balloon.A second medtronic stent was used to keep the dislodged stent to the side of the vessel, with no issues noted.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Product analysis: the device was returned for analysis.A kink was evident to the hypo-tube.The stent was not present on the balloon and did not return for analysis.Bunching was evident to the proximal balloon pillow.The balloon folds remained intact.Crimp impressions were visible on the exposed balloon surface.No deformation evident to distal tip.No other damage was evident to the remainder of the device.Additional information: lot number updated.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18465035
• MDR Text Key: 332319077
• Report Number: 9612164-2024-00127
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 05/23/2024

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 Model Number: RONYX30015X
• Device Catalogue Number: RONYX30015X
• Device Lot Number: 0011694906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/01/2024
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 01/09/2024; 03/12/2024; 05/22/2024
• Supplement Dates FDA Received: 01/29/2024; 03/27/2024; 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2023
• 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