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 Hemolysis (1886); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Renal Failure (2041); Sepsis (2067); Multiple Organ Failure (3261); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Type  Injury  

Event Description

During a literature review, livanova identified an article (amit alam et al., 2023) which described the use of the protekduo cannula for internal jugular cannulation in patients with rv failure.The majority of patients described in the study received rv support post-lvad outside the index lvad operation room.The case study described numerous adverse events across the patients with right ventricular failure.This report is being submitted in relation to the 51 instances of non-device-specific adverse events, including the following: 8 cases of moderate-severe tricuspid regurgitation; 9 cases of multiorgan failure; 3 cases of hemorrhagic cerebrovascular accident; 4 cases of hemolysis; 13 instances of initiation of dialysis (can report as kidney failure in the mdr); 9 cases of sepsis; 5 instances of non-major bleeding.

Manufacturer Narrative

B3.It is unclear from the literature how many separate events occurred and when they occurred.Attempts to gather more information about each patient and event have been unsuccessful.As such, event date(s) is unknown.D4.It is unclear from the literature how many devices were involved in the reported adverse events or what their identifying information is.Attempts to gather more information about the devices, including size and lot number, have been unsuccessful.As such, the device part and lot number are unknown and the udi and expiration date could not be determined.E1.Hospital information for each adverse event was not included in the literature.H4.As the lot number is unknown, manufacture date could not be determined.H10.Livanova manufactures the protekduo cannula.It is unknown where the reported events occurred.This report documents a number of adverse events which were reported in the literature.There was no specific malfunction of the protekduo cannula described in the literature in relation to any of the reported adverse events.It is also unclear from the literature how many individual patients experienced these adverse events, what their outcomes were, when the event(s) occurred, and what specific product was being utilized at the time of the event.Livanova has made multiple attempts to gather more information from the authors.The main author, dr.Amit alam, has responded that he does not have any additional information.Attempts have also been made to contact the centers and physicians referenced in the article who the patients were actually treated by.However, no further information has been provided at this time.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.

• 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: 17476279
• MDR Text Key: 320579086
• Report Number: 2531527-2023-00018
• 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: 08/07/2023

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: 07/10/2023
• Initial Date FDA Received: 08/07/2023
• 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): Other