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 Problem Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

A1.-a6.Patient information was not provided.B3.It is unclear from the literature when the event occurred.Attempts to gather more information about the event have been unsuccessful.As such, the event date is unknown.D4.Device information was not included in the literature.Attempts to gather more information about the device, 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 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 event occurred.It is unclear from the literature if there was a specific malfunction of the device which led to the reported adverse event, what the patient outcome was, when the event 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.(b)(6), 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.

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 cannula thrombus mentioned in the literature.

• 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: 17476291
• MDR Text Key: 320574144
• Report Number: 2531527-2023-00019
• 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