MAUDE Adverse Event Report: THEROX INC IMPULSETM CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number SSO2 EU - 4.0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Thrombosis/Thrombus (4440)

Event Date 12/12/2021

Event Type  Injury  

Event Description

A (b)(6) male patient (weight: (b)(6) kg) who experienced st-elevated myocardial infarction (stemi) (24 hour onset of symptoms) was hospitalized and underwent percutaneous coronary intervention (pci).The pci was performed via radial access.Primary 3 stents were placed in the left anterior descending artery (lad) (proximal to medial, stent des/synergy ii), lad (proximal, stent/des synergy ii), and diagonal branch i (stent/synergy ii).An sso2 therapy was delivered to a patient using the therox downstream console (sn (b)(4)) with bsc impulse catheter (lot #60236430), which was inserted in the right femoral artery, and the sso2 therapy was started without any problems.Approximately 45 minutes after the initiation of the sso2 therapy, the patient experienced chest/thoracic pain despite 2 morphine doses.Due to persistent chest pain, the sso2 therapy was stopped, and an optical coherence tomography (oct) examination was carried out immediately to examine the stents and vessel walls in detail.The dissection was noted in the stent area in the left anterior descending artery (lad) proximal area.The patient received heparin 1x 5.000ie anti-coagulant, ticagrelor, and asa before sso2 therapy.Activated clotting time (act) measurements were 386 before sso2 and 284 after sso2 therapy.The thrombus developed despite given medications to prevent it.The control angiography showed a thrombus in the most proximal stent.The dissection and thrombus formation in this area were confirmed by oct diagnosis.A re-intervention was performed only in the lad proximal area (stent/ drug-eluting stents (des) promus premier select).Dilatation was performed again, and a 4th stent was implanted.The customer stated that the patient is doing well, and a cardiac magnetic resonance imaging (cmri) is scheduled in 5 days after the implantation of 4th stent.The customer provided no further information.No consequences or impact to the patient.Please see the following related mfr report: mfr #2030964-2022-00001 for the downstream console.Mfr #2030964-2022-00003 for the downstream sso2 cartridge.Mfr #2030964-2022-00004 for the merit medicaltm sheath.

Manufacturer Narrative

The therox devices involved in the reported complaint will not be returned for evaluation because no device malfunction was involved, and the devices functioned as intended during the clinical use.Zoll therox sales representative had the opportunity to discuss the case with the customer.The treatment has been discussed in detail; the event log has been reviewed.Zoll planned to debrief with the customer to determine the possible causes for the reported adverse event.According to the customer, there were no reported patient's death or device-related injury, no consequences or impact to the patient.Seems it mean that the customer assesses event of st as not related to therox device.Customer believes that st occurred due to dissection after primary pci.Supersaturated oxygen (sso2) therapy is an adjunctive cardiac catheterization laboratory initiated procedure targeted at the left main coronary artery (lmca) of an acute myocardial infarction (ami) patient after successful percutaneous intervention (pci) with stenting has been performed of the left anterior descending coronary artery.The therox downstream system is indicated for the preparation and delivery of supersaturated oxygen therapy (sso2 therapy) to targeted ischemic regions perfused by the patient's left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (pci) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (ami) symptoms caused by a left anterior descending artery infarct lesion.Event was serious as event required additional intervention.According to available information, event of st assessed as possible related to therox device based on meddev definition: "possible: the relationship with the use of the investigational device or procedure is weak but cannot be ruled out completely.Alternative causes are also possible (e.G.An underlying or concurrent illness/ clinical condition or/and an effect of another device, drug or treatment).Cases were relatedness cannot be assessed or no information has been obtained should also be classified as possible".Additional information requested in queries.St timing and location were relevant, so we cannot exclude relatedness.Additional information is requested.The customer probably will benefit from additional follow up training, which was requested.Event is anticipated (st can occur after pci).The event is possibly related to the device and procedure.

Event Description

A 58-year-old male patient (weight: 89 kg) who experienced st-elevated myocardial infarction (stemi) (24-hour onset of symptoms) was hospitalized and underwent percutaneous coronary intervention (pci).The pci was performed via radial access.Primary 3 stents were placed in the left anterior descending artery (lad) (proximal to medial, stent des/synergy ii), lad (proximal, stent/des synergy ii), and diagonal branch i (stent/synergy ii).Sso2 therapy was delivered to a patient using the therox downstream console (sn (b)(6) with bsc impulse catheter (lot #60236430), which was inserted in the right femoral artery, and the sso2 therapy was started without any problems.Approximately 35 minutes after the initiation of the sso2 therapy, the patient experienced chest/thoracic pain despite 2 morphine doses given to relieve said pain.Due to persistent chest pain, the sso2 therapy was stopped, and an optical coherence tomography (oct) examination was carried out immediately to examine the stents and vessel walls in detail.A dissection was noted in the stent area in the left anterior descending artery (lad) proximal area.The patient received heparin 1x 5.000ie anti-coagulant, ticagrelor, and asa before sso2 therapy.Activated clotting time (act) measurements were 386 before sso2 and 284 after sso2 therapy.A thrombus developed despite medications given to prevent it.The control angiography showed a thrombus in the most proximal stent.The dissection and thrombus formation in this area were confirmed by oct diagnosis.A re-intervention was performed only in the lad proximal area (stent/ drug-eluting stents (des) promus premier select).Dilatation was performed again, and a 4th stent was implanted.The customer stated that the patient is doing well, and cardiac magnetic resonance imaging (cmri) was performed on day five after the implantation of the 4th stent.The cmri showed no evidence of additional worsening of the myocardium.No consequences or impact to the patient were noted.

Manufacturer Narrative

Additional information in b5 (describe event or problem) and h10 (manufacturer narrative) the therox devices involved in the reported complaint will not be returned for evaluation because no device malfunction was involved, and the devices functioned as intended during the clinical use.The treatment was discussed in detail with the customer by zoll therox sales personnel.The event log was reviewed, and follow-up training was provided to the customer.The customer planned to perform optical coherence tomography (oct) measurements in the future to compare vessel condition following percutaneous coronary intervention (pci) with the condition following sso2 therapy; to evaluate the potential impact of the sso2 therapy on the vessel.According to the customer, there was no reported patient's death or device-related injury, and no consequences or impact to the patient.This suggests the customer assesses event of st is not related to therox device.Customer believes that st occurred due to dissection after primary pci.Supersaturated oxygen (sso2) therapy is an adjunctive cardiac catheterization laboratory initiated procedure targeted at the left main coronary artery (lmca) of an acute myocardial infarction (ami) patient after successful percutaneous intervention (pci) with stenting has been performed of the left anterior descending coronary artery.The therox downstream system is indicated for the preparation and delivery of supersaturated oxygen therapy (sso2 therapy) to targeted ischemic regions perfused by the patient's left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (pci) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (ami) symptoms caused by a left anterior descending artery infarct lesion.The risk assessment for this procedure was reviewed with respect to this event.There was no evidence of device malfunction, so those elements of the established risk analysis were not affected.For the procedure itself, the risk analysis does consider the risk associated with a dissection created (or not resolved) during the pci procedure.This is a known risk and can normally be detected by pre-treatment angiography (oct is one of several possible detection methods in the cath lab).This risk resulted in the following contraindication being included in the ifu: "presence of a post-intervention non-stented coronary dissection or perforation".The risk assessment properly identifies the seriousness of this risk, the risk assessment is adequate." event was serious as event required additional intervention.Based on all available information and meddev definitions, event could be assessed as unlikely related to therox device and procedure.Definition of unlikely: "the relationship with the use of the device or procedure seems not relevant and/or the event can be reasonably explained by another cause, but additional information may be obtained".The customer probably will benefit from additional follow up training, which was requested.The event is unlikely related to the device and the procedure.

• Brand Name: IMPULSETM CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): THEROX INC; 17500 cartwright rd; 100; irvine CA 92614
• Manufacturer (Section G): THEROX INC; 17500 cartwright rd; 100; irvine CA 92614
• Manufacturer Contact: kim nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 13200983
• MDR Text Key: 288630842
• Report Number: 2030964-2022-00002
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729344834
• UDI-Public: 08714729344834
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P170027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: SSO2 EU - 4.0
• Device Catalogue Number: 40322-0001
• Device Lot Number: 60236430
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 01/08/2022
• Supplement Dates Manufacturer Received: 02/11/2022
• Supplement Dates FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 89 KG