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

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

A1.-a6.Patient information was not provided.B3.Event date was not provided.D4.Device part and lot number were not provided, so udi and expiration date could not be determined.E1.It is unknown where the reported event occurred.H4.As lot number is unknown, manufacture date could not be determined.H10.Livanova manufactures the protekduo cannula.It is unknown where the reported event occurred.The involved patient(s) reportedly suffered from other medical complications.There was no specific malfunction of the protekduo cannula described in the literature in relation to the reported adverse event.Livanova has made multiple attempts to gather more information from the authors of the article, including details about the locations and timelines for each event, cannula information (size and serial number), final outcome of the patient(s), and more details about any alleged malfunctions.However, no further information has been provided at this time.Following contact with the main author of the article (dr.Brewer), he stated that he was unable to provide any of the requested information due to the nature of this type of systematic review and its dependence on the data provided in primary publications.At the recommendation dr.Brewer, multiple attempts were made at contacting the authors of the seven primary publications included in the literature, however no response has been received at this time.As no further information regarding the event has been provided and there is no known malfunction of the protekduo device, a root cause was not determined and no corrective actions have been identified.If any additional information relevant to the reported event is received, it will be provided in a supplemental report.H3 other text : device availability is unknown.

Event Description

Through a literature review, livanova identified an article (brewer et al., 2023) describing patient survival and complications when the protekduo cannula was used as part of a tprvad system.The studies reviewed included patients with arvf from a variety of causes and the mean duration of support reported was between 10 and 58 days between the five studies.Device related and non-device related complications were reportedly low and the authors reported survival to discharge of 68% across all groups.When survival to discharge was stratified by indication for rvad, patients in the cardiotomy group had an 89% survival, patients with cardiogenic shock had a 42% survival, and patients with respiratory failure had a 60% survival.Six of the seven studies under review reported complications and adverse effects.This report is in relation to two instances of bleeding from the cannula insertion site.Final patient outcome is unknown.As there is no known differentiating information for these events, both are being included in a single report.

Manufacturer Narrative

A review of previous complaints identified 1 prior complaint for this type of issue, for which a specific root cause was not identified.

• Brand Name: PROTEKDUO 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: 17159406
• MDR Text Key: 317628724
• Report Number: 2531527-2023-00014
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/19/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: No
• 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