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

Model Number RONYX30018UX

Device Problems Fracture (1260); Material Deformation (2976)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2024

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

An attempt was made to use one resolute onyx coronary drug eluting stent to treat a moderately tortuous, severely calcified lesion with 100% chronic total occlusion in the proximal/ostium left main (lm) coronary artery /left anterior descending (lad) artery.It was reported that stent deformation occurred in vivo during post deployment.The causative device was a post dilation balloon.A stent fracture was reported to have occurred.The patient is alive with no injury.

Manufacturer Narrative

Product analysis: the device was returned for analysis.Kinks were evident along the hypo-tube.The delivery system returned with the balloon in a post inflated state.The stent was not returned.The reported failures could not be confirmed from analysis of the returned delivery system.No other damaged evident to the remainder of the device.Additional information: the lesion was pre-dilated.Resistance was noted while advancing the device to the lesion.The device did not pass through a previously deployed stent.The post-dilation balloon was another balloon, and was not the stent delivery system balloon.The stent fracture was treated by implanting stent over stent.The patient is alive with no further injury.Event date provided.Gender provided.Lot number updated updates to sections: b.Adverse event or product.B.2.Outcome attributed to adverse event.H.1.Type of reportable event.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

Additional information: there were no issues noted with the other stent used to treat the stent fracture.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: 18951734
• MDR Text Key: 338263568
• Report Number: 9612164-2024-01393
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556997
• UDI-Public: 00643169556997
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX30018UX
• Device Catalogue Number: RONYX30018UX
• Device Lot Number: 0011819105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2023
• 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