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

Model Number 96830-014

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

Patient Problems Hemorrhage/Bleeding (1888); Ischemia (1942)

Event Date 06/06/2022

Event Type  Injury  

Event Description

Medtronic received information via literature regarding a study to explore long-term outcomes in high-risk cases undergoing percutaneous coronary interventions (pci) supported by veno-arterial extracorporeal membrane oxygenation (va-ecmo).All data were collected from a single center between april 2012 and january 2020.The study population included 61 patients and the following medtronic devices were used in the va-ecmo circuit bio-medicus arterial and venous cannulas, a membrane oxygenator and a centrifugal pump (model, serial and lot numbers not provided).Among all patients, 14 in hospital deaths occurred.Ten patients died due to cardiac shock, three due to septic shock, and one patient succumbed to early stent thrombosis.At the one-year point in the study there were 19 deaths and the overall mortality reported was 33 deaths.Based on the available information, none of the deaths were attributed to medtronic products.Among all patients, adverse events included: post-operative cerebral infarction occurred because of hypoperfusion caused by cardiac or septic shock, further revascularization owing to unstable angina at the one-year follow-up, re-admission due to symptomatic heart failure, sepsis, malignant tumor, fracture, end-stage renal disease, aplastic anemia, intraoperative hypotension and surgery was performed safely by increasing the ecmo flow, lower extremity ischemia, hemorrhagic complications which required a blood transfusion.Based on the available information, lower extremity ischemia, hemorrhagic complications which required a blood transfusion may have been attributed to medtronic cannulae.No device malfunctions were reported in the study.

Manufacturer Narrative

Literature citation authors: huang, yi-xiong, zheng-ming xu, li zhao, yi cao, yu chen, yi-gang qiu, ying-ming liu, peng-yu zhang, jiang-chun he, and tian-chang li.Journal name: world journal of clinical cases year: 2022 title of the article: long-term outcomes of high-risk percutaneous coronary interventions under extracorporeal membrane oxygenation support: an observational study.Issue number: 16 volume number: 10 pages: 5266 - 5274 literature reference: https://dx.Doi.Org/10.12998/wjcc.V10.I16.B3 (event date): the online published date has been used as the event date.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.

Manufacturer Narrative

Conclusion: medtronic cannot confirm or deny the complaints of adverse events in cases undergoing percutaneous coronary interventions (pci) supported by veno-arterial extracorporeal membrane oxygenation (va-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 there was no allegation that the patient deaths were related to the use of the medtronic devices.Additionally, there was no evidence confirming the adverse effects were related to any of the bio-medicus one-piece femoral venous or arterial cannulae and there were no device malfunctions reported.The use conditions and therapies (i.E.Pci and ecmo) described in the literature article are considered off-label use and are mitigated through the information for safety (ifu) provided.These off-label use conditions in combination with patient conditions likely contributed to the adverse effects (lower extremity ischemia and hemorrhagic complications) reported.Complaints received 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 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: 17133348
• MDR Text Key: 317214168
• Report Number: 2184009-2023-00540
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K872033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

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: 96830-014
• Device Catalogue Number: 96830-014
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 07/14/2023
• Supplement Dates FDA Received: 07/19/2023
• 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