MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-MEDICUS NG 21 FR VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 96670-121

Device Problem Obstruction of Flow (2423)

Patient Problems Unspecified Infection (1930); Thrombosis/Thrombus (4440)

Event Date 12/08/2022

Event Type  Injury  

Manufacturer Narrative

Literature details: title: percutaneous pulmonary artery cannulation to treat acute secondary right heart failure while on veno-venous extracorporeal me mbrane oxygenation authors: kelly m.Ivins-o¿keefe, michael s.Cahill, arthur r.Mielke, michal j.Sobieszczyk, valerie g.Sams, phillip e.Mason and matthew d.Read journal: asaio doi: 10.1097/mat.0000000000001692.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.

Event Description

Medtronic received information via literature regarding the percutaneous cannulation of the pulmonary artery for conversion from veno-venous to veno-pulmonary artery return ecmo in 21 patients who developed secondary right heart failure.During this study either a 19 or 21 french venous cannula was placed percutaneously into the pulmonary artery via the internal jugular or subclavian vein.No complications occurred during the cannulation procedure itself, nor were any instances of valve damage noted throughout the study.Among all patients, device malfunctions included: replacement of the cannula due to migration into the rv on day 3 after initial cannulation.Among all patients, adverse events included: removal of and eventual replacement of pa cannulas for persistent bacteremia, despite other line exchanges.One patient had persistent thrombus on the cannula that was managed with an increase of their ecmo anticoagulation goals.Among all patients, 3 deaths occurred.One patient experienced a cardiac arrest after a seizure on day 70 of v-p ecmo and was noted to have developed hemopericardium after prolonged resuscitative efforts; autopsy demonstrated a 1mm linear defect in the main pa.Two other patients suffered unexpected cardiac arrests on days 3 and 8 of v-p ecmo, respectively, with both noted to have pericardial effusions requiring pericardiocentesis during on-going resuscitative efforts.Autopsy on one patient demonstrated a 1mm linear defect in the main pa with multiple other intimal abrasions.Based on the available information, none of the deaths were attributed to medtronic product.

Manufacturer Narrative

E1: phone number added.Conclusion: medtronic cannot confirm or deny the complaint of patient death and adverse effects during percutaneous cannulation of the pulmonary artery for conversion from veno-venous (vv) to veno-pulmonary (vp) artery return extracorporeal membrane oxygenation (ecmo) as no product has been returned to date.A root cause of this occurrence cannot be determined without returned product.The device history record could not be reviewed as no lot number was provided.A clinical review was completed with medtronic medical safety and concluded all patients had been on ecmo for a significant amount of time (median 23 [4¿71] days per patient).The use conditions (length of use and placement technique) described in the literature article most likely contributed to the adverse effects and deaths reported, however, they are considered off-label and are mitigated through the information for safety (ifu) provided.Complaints received from january 2022 through may 2023 for similar model numbers were reviewed and showed no trends warranting escalation related to this occurrence.Medtronic has made its supplier aware of this occurrence and will continue to monitor for future occurrences and trends.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: BIO-MEDICUS NG 21 FR VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16290207
• MDR Text Key: 308702429
• Report Number: 2184009-2023-00066
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K845045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 96670-121
• Device Catalogue Number: 96670-121
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 02/03/2023
• Supplement Dates Manufacturer Received: 05/19/2023
• Supplement Dates FDA Received: 05/24/2023
• 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; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 99 KG