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

Model Number	ONYXNG22518UX
Medical Device Problem Codes	Burst Container or Vessel (1074); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: the device was not moved or repositioned in the lesion while inflated.The stent moved when the device was pulled back due to underinflation, as the stent was not sufficiently expanded prior to attempting removal of the balloon due to the burst.The balloon was still slightly inflated in a ruptured manner, inside the stent after the burst occurred.Sufficient time was given to allow the balloon to fully deflate prior to attempting removal.On removal of the balloon from the stent, resistance was not encountered as the device was retracted over the guidewire.There were no issues noted with the 2.0x20mm euphora balloon used during the procedure.Correction: annex e code.Medtronic submits this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.
Additional Manufacturer Narrative
Image analysis: procedural images were received which confirm a jacket of stents in the right coronary artery (rca).The target lesion in the proximal lcx is confirmed.The proximal lcx was pre-dilated, followed by the attempted delivery of a stent.The alleged balloon burst could not be confirmed as no contrast was seen to be leaking into the vessel, but the distal end of the stent flared suggesting that some pressure was applied to the balloon.The stent delivery system was pulled back into the guide catheter and the stent remained in the proximal lcx/lm.In attempts to retrieve the stent, balloons were delivered into the vessel but the stent remained in the vessel.The removal failed.The stent appeared to have been bunched during the retrieval process.Ultimately, a stent was delivered to the vessel at the site of the bunched stent.This stent was expanded and the dislodged bunched stent was jailed in the vessel.Another stent was delivered distal to the site of the dislodged stent and deployed.Final contrast injection into the left coronary system showed good flow to the vessel with resolution of the initial target lesion.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 or Problem Description
During a procedure an attempt was made to use one onyx frontier coronary drug eluting stent (des) to treat a moderately tortuous, moderately calcified lesion exhibiting 85% stenosis located in the proximal circumflex (cx) artery. the device was inspected with no issues noted.Negative prep was performed with no issues noted.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 a balloon burst occurred during stent deployment on the first inflation at 10 atm.The balloon ruptured and the device was pulled back into the left main which also pulled the stent back into the left main, with half of the stents length left in the circumflex artery.A 2.0mm x 20 euphora balloon was placed in the stent and a pressure of 4 atm was applied to try to pull the stent out through the guide without success.A 2.0 x 12 non-medtronic balloon was then used with up to 6 atm of pressure applied to try to pull the stent out through the guide with no success.A 4.0 x 8mm onyx frontier des was then deployed within the 2.25 x 18 onyx frontier stent in the left main to crush the stent against the artery wall. the procedure was completed and the proximal cx artery was treated using a 2.5 x 8 mm non-medtronic balloon and a 2.25 mm x 18 mm non-medtronic stent.The patient is reported to be alive with no further injury.
Additional 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.

• Brand Name: ONYX FRONTIER
• Common Device Name: 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: 19267887
• Report Number: 9612164-2024-02183
• Device Sequence Number: 7494807
• Product Code: NIQ
• UDI-Device Identifier: 00763000511210
• UDI-Public: 00763000511210
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/18/2026
• Device Model Number: ONYXNG22518UX
• Device Catalogue Number: ONYXNG22518UX
• Device Lot Number: 0011829802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 05/09/2024; 06/27/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 05/14/2024; 07/03/2024
• Date Device Manufactured: 06/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 76 KG