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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Stroke/CVA (1770); Sepsis (2067); Thrombocytopenia (4431); Heart Failure/Congestive Heart Failure (4446); Gastrointestinal Hemorrhage (4476)

Event Type  Death  

Event Description

During a literature review conducted on july 5, 2022, livanova identified a report (oliveros, collado et al.2021) regarding a group of patients from a single center who were placed on ecmo between august 2015 and february 2018 and required placement of the protekduo cannula.This group consisted of 11 patients who were diagnosed with acute rv failure and several other conditions including developed atrial arrhythmias (4), acquired nosocomial pneumonia (2), right ventricle failure (1), cardiomyopathy leading to biventricular failure (1), massive pulmonary embolism (1), rv acute myocardial infarction (1), and mitral valve regurgitation (1).The length of support ranged from 11 to 154 days.The literature indicated that patients utilizing the livanova protekduo device (size not specified) experienced a survival rate of 82% at 30 days and 72% at 180 days.The following complications were observed during the procedures: stroke (18.2%), sepsis (63.6%), massive gastrointestinal bleed (45.5%), and heparin-induced thrombocytopenia (54.5%).Six of the patients were successfully weaned from the protekduo devices and 1 patient required veno-venous extracorporeal life support.None of the complications were related to device insertion.The authors noted that acute rv failure has a reported mortality of 50% and the overall survival rate in the protekduo cohort was 81.8% at 30 days (9 patients) and 72.7% at 180 days, which suggests a benefit with mechanical support.Mortality was seen in 36.4% of cases, and in all of these cases the patients died after families opted to provide comfort care and discontinued mechanical support.The literature did not identify a link between the use of the protekduo and the adverse events or deaths, but concluded that use of the protekduo cannula was associated with a reduced mortality rate for rv failure patients.No specific device malfunction was reported.

Manufacturer Narrative

The literature did not specify the specific size of the protekduo cannula used, so part number is unknown, and the lot number was not provided so udi and expiration date could not be determined.The literature did not provide any serial or lot numbers so the device manufacturing date could not be identified.Livanova manufactures the protekduo cannula.The incidents occurred in the (b)(6).This event is being filed in response to discovery of literature detailing adverse events and deaths during procedures utilizing the protekduo cannula.However, there was no reported device malfunction and no specific allegation was made that the protekduo was the cause of any of the reported events.As no specific details about each event was provided, a single report is being filed to document the details of this literature review.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 ; 2812287200
• MDR Report Key: 15166132
• MDR Text Key: 297263864
• Report Number: 2531527-2022-00037
• 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
• Report Date: 07/05/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 08/04/2022
• 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): Death; Other