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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Swelling/ Edema (4577)

Event Date 03/18/2021

Event Type  Injury  

Event Description

Medtronic received information via literature a regarding retrospective review of all patients who underwent rigid bronchoscopy under extra corporeal membrane oxygenation (ecmo) support for the management of bronchotracheal stenting.All data was collected from a single center between january 2009 and december 2019.The study population included 11 patients (predominantly male, mean age 54 years).Medtronic bio-medicus arterial and femoral cannulae were used during ecmo.Among all patients, 4 deaths occurred.Based on the available information, none of the deaths were attributed to the medtronic products.Among all patients, adverse events included: stent removal was not possible, migration of the stent occurred after surgery, stenosis recurred early, one case of severe bronchospasm, four cases of tracheal bleeding, one of which required a transfusion of 2 units of red blood cells (rbcs), four other blood transfusions (1 or 2 units of rbcs) were necessary for conditions other than hemorrhagic phenomena, reintubation, inguinal hematoma and inguinal lymphocele, which was drained after a month.Based on the available information, the inguinal hematoma and the inguinal lymphocele adverse events may have been attributed to the medtronic products.Among all patients, no device malfunctions occurred.

Manufacturer Narrative

Literature article details: title of article: bronchotracheal stenting management by rigid bronchoscopy under extracorporeal membrane oxygenation (ecmo) support: 10 years of experience in a tertiary center authors: sabrina meyer, anne-sophie dincq, lionel pirard, sebahat ocak, jean-paul d¿ode´mont, philippe eucher, beno¿it rondelet, andre´ gruslin, and laurie putz journal name: canadian respiratory journal year: 2021 literature reference:10.1155/2021/8822591 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 two extra corporeal membrane oxygenation (ecmo) complications observed during rigid bronchoscopy under ecmo for the management of bronchotracheal stenting.One patient developed an inguinal hematoma, and another developed an inguinal lymphocele, however, as no product has been returned to date, the complaint cannot be confirmed.A clinical review was completed with medtronic medical safety and the review concluded that there were no device malfunctions reported and the adverse events reported in the literature article were most likely the result of procedural techniques and patient anatomy, and the adverse events were not directly related to a device malfunction.Additionally, during the time period reported in the literature article, the bio-medicus nextgen femoral venous and bio-medicus nextgen femoral arterial / jugular venous cannula were only ¿intended for use up to 6 hours¿ and use beyond 6 hours would be considered off-label.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.Medtronic will continue to monitor for future occurrences and trends for this device.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: 15202363
• MDR Text Key: 297682171
• Report Number: 2184009-2022-00208
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K180453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

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: 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: 07/11/2022
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 09/16/2022
• Supplement Dates FDA Received: 10/03/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male