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

Model Number NCEUP3012X

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems Cardiac Arrest (1762); Obstruction/Occlusion (2422); Vascular Dissection (3160); Insufficient Information (4580)

Event Date 05/09/2022

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An attempt was made to use a nc euphora balloon catheter.The lesion was pre-dilated with a non-compliant balloon.A 2.5 x 18mm non-mdt (medtronic) stent was then implanted into the lesion.The nc euphora device was inserted into the non-mdt stent.After the balloon was placed inside the stent it was inflated but either the balloon did not inflate or it could not be seen under fluoro.The technician pulled negative on the inflation device and re-inflated the balloon and this time the balloon was seen to be inflated under fluoro.The balloon was inflated for a directed time and then the inflation device was pulled negative to deflate the balloon.It was reported that the balloon would not deflate and was still inside the patient.Multiple attempts were made to deflate the balloon with different devices, wires, catheters, micro-catheters and guides, but all attempts were unsuccessful.It was also reported that at some point in time the artery dissected and the shaft of the nc euphora device broke off.After the shaft broke the balloon remained inflated and part of the catheter was left in the patient as well as the inflated balloon.A number of attempts were made to puncture the balloon, snare the balloon and remove the balloon, but none were successful.It was stated that the case lasted approx.10 hours.The procedure was stopped and the patient was sent to the intensive unit care (icu) with the balloon still inflated in the patient¿s artery.The balloon remains in the patient.The patient deceased the next day.It was subsequently reported that the device was successfully retrieved from the patient during autopsy.

Manufacturer Narrative

Product analysis summary: the device returned with a detachment on the transition shaft proximal to the exchange joint.The proximal section of the detachment did not return for analysis.The returned distal section measured approx.44.5cm.The transition shaft material was jagged and uneven on the detachment site.The transition shaft was stretched, flattened and kinked.The exchange joint was stretched and the guidewire entry port was torn.The stretched exchange joint measured greater than 13mm.The measurement of the distal shaft, from the exchange joint to the proximal balloon bond measured approx.33cm.The distal shaft was stretched and kinked.Blood was visible in the guidewire lumen.The distal section of the distal shaft, and the proximal balloon bond were necked.Bunching was also evident on this section of the distal shaft.It was not possible to identify the inflation lumen on the necked section of the distal shaft and proximal balloon bond.It was not possible to measure the length of the necked balloon bond due to the condition of the device.The balloon returned partially inflated with some contrast visible in the balloon.Blood was visible on the surface of the balloon.There did not appear to be a burst evident to the balloon.It was not possible to perform inflation or deflation testing due to the condition of the device.No deformation evident to the distal tip.No other deformation evident to the remainder of the device.Procedural images were reviewed in conjunction with the procedural notes.The target lesion in the proximal lcx was identified and it was confirmed that the lesion was pre-dilated with what appears to have been a 2.5 x 6mm euphora balloon.This was followed by delivery and deployment of a non-medtronic stent.The stent conformed to the lesion tortuous morphology.The following images showed the presence of what appears to be the nc euphora balloon.There were two images where the inner shaft markers were visible but there was no evidence of balloon inflation with contrast.But there may have been a small volume of contrast in the balloon, evidenced by a small blush of contrast in the balloon area.The third image shows the full inflation of the nc euphora balloon with no evidence of air or any other anomaly in the balloon.There is no evidence from the images to identify the root cause for the inflation and deflation difficulties.But images confirm that the nc euphora balloon remained inflated and that the lcx distal to the balloon remains occluded.Additional information: an attempt was made to use a nc euphora balloon catheter to treat a lesion located in the left circumflex artery.The lesion was pre-dilated using a 2.5 x 6mm euphora rx balloon catheter and was inflated at 14atm.After the balloon was placed inside the stent it was inflated at 6atm but either the balloon did not inflate or it could not be seen under fluoro.The technician pulled negative on the inflation device and re-inflated the balloon at 12atm and this time the balloon was seen to be inflated under fluoro.Multiple attempts were made to deflate the balloon with different devices including, balloons, snares, wires, catheters, micro-catheters and guides, but all attempts were unsuccessful, two euphora ptca balloon catheters and gooseneck microsnares were among the devices used.Code blue was called following intervention attempts and a heart pump device was implanted.The procedure lasted approximately 9 hours.The patient was a non surgical candidate.The cause of death was related to the nc euphora balloon which was unable to be deflated.Patient dob, gender and relevant history 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: prior to the procedure the patient presented to hospital with worsening exertional dyspnea and chest pain, and was on max medical therapy as tolerated.During the nc euphora rx device preparation there were no issues experienced with the removal of the stylette and the balloon protector.The balloon was inspected prior to threading onto the guide wire into the vasculature, to ensure that there was no damage to the device.After 6 atm, the technician pulled negative on the inflation device and then re-inflated the balloon to 12atm, and this time the balloon was seen to be inflated under fluoro.The dissection was due to attempts to capture/deflate the nc euphora balloon and/or to crush stent.Code blue was called following i ntervention attempts as the patient became hypotensive and had severe chest pain.The patient was intubated and a heart pump device was implanted.There was no malfunctions experienced with the other medtronic devices used during the procedure.The autopsy procedure was only used to remove the device and did not share the cause of death.A 1:1 concentration of contrast/saline was used during the procedure.Patient weight 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.

• 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: 14630685
• MDR Text Key: 293521403
• Report Number: 9612164-2022-02150
• 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
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2024
• Device Model Number: NCEUP3012X
• Device Catalogue Number: NCEUP3012X
• Device Lot Number: 223907076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2022
• 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; Death
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 85 KG