MAUDE Adverse Event Report: MEDTRONIC MEXICO NC EUPHORA RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,

Model Number NCEUP3515X

Device Problems Burst Container or Vessel (1074); Entrapment of Device (1212); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920); Material Deformation (2976)

Patient Problems Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Myocardial Infarction (1969); Shock (2072); Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 12/01/2023

Event Type  Death  

Event Description

An attempt was made to use one nc euphora coronary balloon catheter to treat a mildly tortuous, severely calcified lesion with 70% stenosis in the mid left anterior descending (lad) 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.It was reported that a balloon rupture occurred during balloon inflation.The balloon had been inflated to 10 atm for 15 seconds, 14 atm for 20 seconds and 18 atm for 20 seconds prior to the rupture.The balloon deflated upon rupture and could not be advanced or withdrawn.An effort was made to advance a non-medtronic guide extension catheter over the balloon shaft, but this was unsuccessful as the distal end of the balloon catheter broke off and remained in the lad.The patient was sent to surgery to have the balloon material and radiopaque markers removed.The patient is alive and still in the hospital.

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.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

Additional information: annex d code added.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

Additional information: the device was not kinked and re-straightened during use.The device was mot moved or repositioned while inflated.Resistance was noted during attempt to withdrawal the device.Excessive force was not used.All the balloon fragments were removed during surgery.It was later reported that the patient expired.Product analysis: the device was returned for analysis.The luer was detached from the device.Kinks evident to the hypo-tube.A complete radial burst occurred.It appeared the proximal balloon bond/ inflation lumen material expanded leading to the burst.The material distal of the burst site detached.The inner member was stretched.Kinks and a twist were evident to the stretched portion of the inner member.The marker bands were not present on the inner member.The tip was also detached from the inner member and the material at the detachment site was stretched and uneven.It was not possible to pressurize the device and perform leak/burst test due to the condition of the device.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

Additional information: right radial access was obtained.A 3.5 ebu launcher device was engaged in the left main (lm).Percutaneous transluminal coronary angioplasty (ptca) was performed with a 2.75mm euphora rx balloon to the proximal lad.A 2.75x34mm onyx frontier stent was then delivered and deployed in the proximal/mid lad.The nc euphora balloon was inflated in the deployed stent but ruptured and deflated.The balloon was entrapped in the onyx frontier stent.Femoral access was obtained and multiple wires and over the wire (otw) balloons were attempted to cross beside the balloon in an effort to retrieve or crush it; however, these efforts were unsuccessful.St depressions were noted on the monitor.There was thrombus formation around the balloon and angiography demonstrated total occlusion at the side of the balloon at the lad.The patient became very uncomfortable and was intubated.Hemodynamics became fragile.There were two short ventricular fibrillation runs with good response to defibrillation.A non-medtronic left ventricular assist device was placed via right cfa access.The patient was stabilized and sedated on propofol.Amiodarone was started.The patient was sent to surgery to have the balloon material and radiopaque markers removed via salvage coronary artery bypass graft surgery (cabg).The cause of death was cardiogenic shock, as a consequence of the cabg/acute myocardial infarction (ami) caused by the balloon rupture.Date of death provided.Date of birth and full initials provided.Medical history 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

Additional information: there was no other complaint with the other medtronic devices used during the procedure.Patient gender provided.Correction: other medtronic devices used during the procedure include a 6f 4ebu launcher, 6f al launcher, 2.75x25mm euphora, 1.25x10mm sprinter legend x 2, 2.0x12mm sprinter otw.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: NC EUPHORA RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18362060
• MDR Text Key: 330932196
• Report Number: 9612164-2023-06078
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00643169396333
• UDI-Public: 00643169396333
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141090
• 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,Followup,Followup,Followup,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NCEUP3515X
• Device Catalogue Number: NCEUP3515X
• Device Lot Number: 227393003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2023
• 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; Death
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 65 KG