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

Catalog Number RONYX35034X

Device Problems Inflation Problem (1310); Leak/Splash (1354); Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 04/30/2023

Event Type  Injury  

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.

Event Description

An attempt was made to use one resolute onyx coronary drug eluting stent to treat a non-tortuous, non-calcified lesion with 50% stenosis in the proximal left anterior descending (lad) artery.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated using a 2.0x20mm sprinter balloon.The resolute onyx did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that inflation difficulties occurred during balloon inflation at 12 atm.The stent balloon was dysfunctional.After a non-medtronic wire was crossed into distal lad and balloon pre-dilatation was done, the resolute onyx stent was deployed but the balloon was not properly functioning despite changing the balloon indeflator.It was detailed that the stent balloon was removed and a 3.5x20mm nc euphora at 22 atm was used to properly inflate the stent with excellent final angiographic result.The patient is alive with no injury.

Manufacturer Narrative

Additional information: there were no issues noted with the sprinter balloon.The resolute onyx device was moved and repositioned while inflated.There was partial balloon inflation at 8 atm but it did not reach nominal pressure and did not inflate properly.The indeflators were functioning properly with the pre and post dilatation balloons but not with the stent.The nc euphora was inflated to higher pressure than the nominal pressure due to under deployment of the stent due to the improper inflation encountered with the stent.Initial reporter phone number provided.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: the device was returned for analysis.The device returned with balloon folds expanded.Blood was visible in the balloon.The balloon failed negative prep.On pressurization of the device, liquid was observed exiting the balloon working length.The balloon failed to maintain pressure.Upon visual inspection of the device, a pin hole was observed on the balloon material.There was no deformation to the distal tip.No other damage evident to the remainder of the device.Image analysis: procedural images provided from the account confirm the presence of a lesion in the proximal lad.The account reported the lesion morphology as non-tortuous, non-calcified lesion with 50% stenosis.There may have been a degree of calcification or fibrotic lesion present that was not visible in the two-dimensional images as the pre-dilation, deployed stent profile and the post dilation balloon appeared to conform to the lesion morphology.The lesion showed an irregular profile that appeared to prevent full concentric balloon or stent expansion.The balloon used for post dilation appears to have contrast leak due to the presence of air in the balloon and the evidence of contrast in the vessel distal to the lesion in which the balloon was inflated.The root cause of the stent inflation difficulties may have been due to a leak in the delivery system balloon that initially retained pressure in order to achieve par tial stent deployment that required additional post dilation.The vessel morphology may have caused damage to the balloon material resulting in the issues encountered.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: 16885506
• MDR Text Key: 314726170
• Report Number: 9612164-2023-01921
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 07/25/2023

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 Catalogue Number: RONYX35034X
• Device Lot Number: 0011367779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 05/13/2023; 07/19/2023
• Supplement Dates FDA Received: 06/08/2023; 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2022
• 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