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

Model Number RONYX20022JX

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2024

Event Type  malfunction  

Event Description

An attempt was made to use one resolute onyx coronary drug eluting stent (des) to treat a mildly tortuous and mildly calcified lesion located in the circumflex artery.The blood vessel diameter was 2mm and the lesion length was 22mm. the device was inspected prior to use with no problems observed.Negative prep was performed with no problems observed.Pre-dilatation of the target lesion was  performed with a 2mm non-medtronic cutting balloon at 6atm. the remaining stenosis rate and condition after dilation was described as good.  the device did not pass through a previously placed stent.Resistance/discomfort was not encountered when delivering the stent.Excessive force was not applied during delivery.  it was reported that on the cine the 2mm resolute onyx des appeared to have expanded considerably more than the 2mm non-medtronic cutting balloon.The resolute onyx balloon was inflated at 15 atm. no patient health damage was reported.

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.

Manufacturer Narrative

Product analysis summary: the device was returned to medtronic for evaluation.Device returned with no stent present on the balloon as it had been implanted into the patient.The balloon folds returned expanded.For a small vessel 22mm stent, the markerband spacing measured approx.24mm which is within markerband spacing specification.The balloon was inflated to 12 atm nominal pressure and the diameter measured 2.23mm.The specification of a balloon diameter at nominal pressure for a small vessel 22mm stent measures 2.25mm with a stent id of 2.00-2.50mm.The balloon was then inflated to 15atm, and the diameter measured 2.35mm.The balloon diameter of 2.35mm with a pressure of 15atm still falls within the specification of a balloon diameter at nominal pressure for a small vessel 22mm stent with a stent id of 2.00mm-2.50mm.No other damage was evident on the remainder of the device.Image analysis: two still fluoroscopic images were provided to support the size difference allegation for the resolute onyx and competitor cutting b alloon.Both devices labelled with 2.0mm diameter.The compliance charts for each of the products confirm that the stent and balloon diameter at nominal pressure for each of the products should read 2.05(resolute onyx) and 2.02(competitor).But it is not possible to make an accurate measurement from the images provided.Although the cutting balloon does appear to have a smaller profile.But the cutting balloon and stent products have different characteristics and there is no labelling claim on the resolute onyx to state that the profile of the resolute onyx and cutting balloon should appear the same on fluoroscopy.It is not possible to make a conclusion based on the images provided.Additional information: the lesion had 75% stenosis.The stent diameter was determined to be 2.10mm.Post dilation was not performed.Intravascular ultrasound (ivus) and the 2mm non-medtronic cutting balloon were used to determine the size of the stent required to treat the lesion.Intravascular ultrasound (ivus) was used to determine the diameter of the stent.It is not possible that there was a mix up at the account with a different device, and the device was not swapped by mistake.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: 18976991
• MDR Text Key: 338548683
• Report Number: 9612164-2024-01448
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX20022JX
• Device Catalogue Number: RONYX20022JX
• Device Lot Number: 0011717497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2023
• 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