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

Model Number 96570-121

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

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

Event Date 06/13/2022

Event Type  Injury  

Event Description

Medtronic received information via literature regarding outcomes of transferred adult venovenous and venoarterial extracorporeal membrane oxygenation patients.All data were collected from a single center between june 2012 and sept 2020.The study population included 126 patients (predominantly male; mean age 45 years), some of which were treated with medtronic bio-console and bio-trend instruments, and medtronic bio-medicus cannulae (serial/lot numbers not provided).Multiple additional manufacturers' devices were noted in the literature also.Among all patients, adverse events included: bleeding on cannula site, and lower limb ischemia.Based on the available information, these adverse events may have been attributed to the medtronic bio-medicus cannulae.Among all patients, device malfunctions included: clotting of ecmo system and pump failure.Based on the available information, these malfunctions may have been attributed to the medtronic bio-console product.Among all patients, no deaths occurred.No additional adverse patient effects or product performance issues related to the medtronic devices were reported.There were no adverse patient effects or product performance issues related to the medtronic bio-trend devices reported.

Manufacturer Narrative

Literature details: title: outcomes of transferred adult venovenous and venoarterial extracorporeal membrane oxygenation patients: a single center experience, authors: yang-chao zhao, xi zhao , guo-wei fu, ming-jun huang, hui zhao, zhen-qing wang, xing-xing li, jun li, journal: frontiers in medicine, volume 9, 2022, doi: 10.3389/fmed.2022.913816.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

Conclusion: medtronic cannot confirm or deny the complaint of cannulation site bleeding and lower limb ischemia in "transferred adult venovenous and venoarterial extracorporeal membrane oxygenation patients", as no product has been returned to date.A root cause of this occurrence cannot be determined without returned product.Discussion with medtronic medical safety was conducted on 08 february 2023 and review concluded none of the adverse events reported a device malfunction that would have caused or resulted in the reported adverse event.During the time period reported in the literature article, the nextgen bio-medicus one-piece femoral arterial / jugular venous cannula were only ¿intended for use up to 6 hours¿ and use beyond 6 hours would be considered off-label.It wasn't until december 2020, that medtronic released the bio-medicus nextgen cannulae ecmo supplemental ifu evaluation following the fda's emergency use authorization guidance for covid19.Cannulation site bleeding and ischemia are not new or unexpected adverse events associated with the use of these cannula devices and are predicted as known or foreseeable risks within risk management documentation.The device history record could not be reviewed as no lot number was provided.Complaints received from june 2012 through february 2023 for similar model numbers were reviewed and showed no trends warranting escalation related to this occurrence.Medtronic will continue to m onitor 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 ARTERIAL 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: 16036026
• MDR Text Key: 306070668
• Report Number: 2184009-2022-00457
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K142673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

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: 96570-121
• Device Catalogue Number: 96570-121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 02/15/2023
• Supplement Dates FDA Received: 03/08/2023
• 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): Other
• Patient Age: 59 YR
• Patient Sex: Male