MAUDE Adverse Event Report: CARDIACASSIST INC. PROTEK DUO VENO-VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

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

Patient Problems Bacterial Infection (1735); Endocarditis (1834)

Event Type  Injury  

Manufacturer Narrative

Livanova manufactures the protekduo cannula.It is unknown where the reported event occurred.The involved patient reportedly suffered from severe covid-19 pneumonia, which can lead to other medical complications.There was no specific malfunction of the protekduo cannula described in the literature in relation to the reported adverse event.If any additional information relevant to the reported event is received, it will be provided in a supplemental report.Device unknown.

Event Description

Through a literature review (morton, heindl - 2023), livanova became aware of an adverse event which occurred on a patient utilizing a protekduo device.The literature described a 48-year-old female patient suffering from severe covid-19 pneumonia who developed a nosocomial bloodstream infection and tricuspid valve endocarditis following prolonged vv-ecmo support.The patient was on support for 120 days.The literature indicated that the infection and endocarditis were likely a result of the prolonged placement of the intravascular vv-ecmo cannula and intracardiac protekduo device.

Manufacturer Narrative

E1.Hospital information provided: (b)(6).H10.Livanova has made multiple attempts to gather more information from the authors of the article.Three of the authors involved were eventually able to be reached (dr.Kara morton, dr.Stephen clarkson, dr.Mustafa ahmed.).Dr.Clarkson stated that the information requested is not available, as these were historic cases.However, he did state that these episodes were likely a result of prolonged hospitalization and prolonged indwelling catheters in a high risk patient and not as a result of a specific device-related malfunction.Given the significant illness these patients faced, dr.Clarkson indicated that these cases highlight concerns for prolonged critical illness and prolonged indwelling catheters in general and not any specific malfunction of the device itself.The device was not made available for investigation at livanova.As an investigation could not be performed, an exact root cause could not be determined and no specific corrective actions were identified.However, given the critical illness of the patient and the commentary provided by the customer, the adverse event was most likely a result of the patient condition and not directly related to a device malfunction.A dhr review could not be performed, as no lot number was made available.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: PROTEK DUO VENO-VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer (Section G): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: ryan coyle ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 16667835
• MDR Text Key: 312586840
• Report Number: 2531527-2023-00006
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2023
• 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): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female