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

Catalog Number NCEUP3012X

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

Patient Problems Cardiac Arrest (1762); Chest Pain (1776); Non specific EKG/ECG Changes (1817); Shock (2072); Obstruction/Occlusion (2422); Vascular Dissection (3160); Insufficient Information (4580)

Event Date 07/26/2023

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 nc euphora coronary balloon catheter to treat a severely calcified, moderately tortuous lesion with 95% stenosis in the proximal left anterior descending (lad) artery.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was not 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 burst occurred at 16 atm during balloon inflation.It was detailed that the balloon was delivered to the site of the heavily calcified lesion in the proximal lad.After the first inflation the balloon ruptured and became caught, or hung up at the lesion site of inflation.There were removal difficulties as the balloon appeared to be caught on the calcium, despite several attempt to pull the catheter delivery system and balloon back into the guide catheter.The patient deceased.The cause of death and circumstances surrounding the death are reported as cardiac arrest from flow disruption in the target vessel lad.

Manufacturer Narrative

Additional information: annex d codes 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 lesion had 90-95% stenosis.The device was being used to pre-dilate the lesion.The device was not moved or repositioned while inflated.Due to 8/10 chest pain, a balloon pump was inserted, with improvement in chest pain to 4/10.The patient remained hemodynamically stable while multiple attempts made to re-wire the lad, after losing wire position with the initial lad wire pulled out by accident.Cardiothoracic (ct) surgery was consulted, however the patient was not a candidate for off-pump surgery due to the heavily calcified aorta.Multiple attempts were made with eventual success to advance a wire beside the ruptured balloon, and along with a 1.5 balloon, the nc euphora balloon was eventually removed being pulled back with some force.It was detailed that the marker band was present throughout the case at the site of inflation.After the balloon was removed from the patient the balloon marker remained inside the patient until much later in the case when additional balloon inflations were performed.The marker portion of the balloon catheter then came out of the vessel.A vessel dissection occurred trying to re-wire around the lesion, and st elevation was noted.The dissection plane was near the calcified lesion making it impossible to re-wire the true lumen of the lad.Cardiogenic shock and cardiac arrest ensued following the dissection.This was treated with vasoactive medications and acls protocols, including cardiopulmonary resuscitation (cpr) for 30 minutes without success.A drug eluting stent was also placed in this time.The physician did assess that the death event was directly related to the use of the relevant device.Patient race ethnicity updated.Relevant history updated.Section b.2.Outcome attributed to adverse event updated.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 dissection was caused by a non mdt wire.Two onyx frontier drug eluting stent was also placed in this time.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: 17448107
• MDR Text Key: 320277667
• Report Number: 9612164-2023-03513
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00643169395862
• UDI-Public: 00643169395862
• 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
• Report Date: 09/11/2023

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: NCEUP3012X
• Device Lot Number: 226241604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 08/08/2023; 08/10/2023; 09/01/2023
• Supplement Dates FDA Received: 08/10/2023; 08/16/2023; 09/11/2023
• Date Device Manufactured: 03/23/2023
• 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): Death; Other; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White