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

Model Number ONYXNG35038UX

Device Problems Deflation Problem (1149); Detachment of Device or Device Component (2907)

Patient Problems Dyspnea (1816); Pain (1994); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Date 03/19/2024

Event Type  Injury  

Event Description

The patient presented to hospital with a non-st-elevation myocardial infarction (nstemi), indicated with elevated enzymes.An attempt was made to use one onyx frontier coronary drug eluting stent (des) to treat a moderately tortuous, severely calcified lesion with 90% stenosis in the distal left main (lm) coronary artery.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.The device 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 the device would not deflate at the lesion site.The left anterior descending (lad) artery and the distal left main were pre-dilated with a 2.0x15mm euphora balloon for several inflations up to 14 atm.The balloon was removed with ease with no complications.A non-medtronic (mdt) guide extension catheter (gec) was inserted along with an 2.0x15mm nc euphora balloon to the lad and lm, and several inflations as high as 20 atm were completed.The balloon was removed with ease with no complications, along with the gec.A 3.5x12mm non-medtronic intravascular lithotripsy device was inserted towards the lm and ostial circumflex (cx) artery.Eight rounds of lithotripsy were performed in the lm and ostial cx.This device was removed with ease and no complications.The 3.5x38mm onyx frontier des, was then inserted for stenting of the distal lm towards the cx artery.The stent was inflated and deployed at 14 atm for approximately 10-12 seconds.Negative pre ssure was pulled on the inflation device with little to no relief, as contrast could still be seen within the balloon.Negative pressure was continually pulled and when attempting to remove the stent balloon, the stent shaft broke free from the plastic (yellow portion) on the stent device leaving the balloon in place, still inflated within the artery.Several interventional wires were inserted to cross the cx artery past the inflated stent balloon.Once in a safe position several balloons, ranging from 1.20mm to 3.00mm, were used to either retrieve the stent balloon, deflate the stent balloon, or burst the stent balloon.During this time the patient complained of pain and the inability to breathe.The patient became hemodynamically unstable and was administered pressors with increased oxygen support, and was intubated.Several more balloon inflations were performed at various sizes and atmospheres.All balloons were removed with ease and no complications.A 4.0x8mm onyx frontier stent was deployed at 16 atm for approximately 10-12 seconds in the lm artery.The stent balloon was removed with ease, and no complications.A 2.75x12mm onyx frontier stent was deployed at 15 atm for approximately 10-12 seconds in the cx artery.The stent balloon was removed with ease, and no complications.Right femoral access was obtained, and existing equipment was removed from the radial access site.A 3.5 guide catheter engaged the left coronary ar tery system.An interventional 0.014 wire was inserted and several balloons varying in size were used in the affected area.All balloons were inflated, deflated, and removed with ease, and no complications.A further two onyx frontier stents were placed and deploy ed with no complications.This intervention crushed and jailed the inflated 3.5x38mm onyx frontier stent balloon within.An intra-aortic balloon pump (iabp) was placed, and the patient was sent to the critical care unit (ccu). the inflation device was prepped as normal using equal 50/50 contrast and heparinized saline.The patient is alive with no further 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.

Manufacturer Narrative

Additional information: five still fluoroscopic images were provided showing the cto in the left coronary system.The presence of contrast in the inflated balloon suggests confirmation of the deflation difficulties.Additional stents were deployed in the vessels and it appears that better flow was achieved in the vessels.The images failed to identify the root cause for the reported deflation difficulties.There were no difficulties noted when removing and prepping the stent prior to use.The stents balloon was inflated once prior to the deflation difficulties.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: ONYX FRONTIER
• 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: 19104803
• MDR Text Key: 340146784
• Report Number: 9612164-2024-01797
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00763000511623
• UDI-Public: 00763000511623
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONYXNG35038UX
• Device Catalogue Number: ONYXNG35038UX
• Device Lot Number: 0012109389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Date Device Manufactured: 01/12/2024
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 85 KG