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

Model Number 5140-5131

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 11/29/2022

Event Type  Injury  

Manufacturer Narrative

A1., a4.-a6.Patient identifier, weight, ethnicity and race were not provided.D4.Device serial number was not provided, so udi and expiration date could not be determined.D7a.While device was not technically reprocessed and reused, it was "reused" in that it was not removed from the patient and replaced with a new device for post-operation support.H4.Device serial number was not provided, so manufacture date is unknown.H8.While device was not technically reused, it was not removed from the patient and replaced with a new device for post-operation support and this event only occurred after the "second" use.However, this was a continuous use of the device so "initial use" was selected.H10.Livanova manufactures the protekduo device.The reported event occurred in st.Louis, missouri.Many attempts were made to retrieve additional information from one of the main authors of the article, dr.Kunal kotkar.He eventually responded and was unable to provide additional information, however provided contact information for dr.Amit pawale who was the senior author and one of the operating surgeons on the case.A call was scheduled between dr.Amit pawale, a livanova medical affairs expert, and the livanova quality team to discuss the case.During the discussion, dr.Pawale confirmed details about the size of the cannula, location of the event and patient pre-existing conditions.He also indicated that he does not think the reported tricuspid regurgitation (tr) was directly related to cannula itself, but rather the unconventional way in which it was used for this patient.Some additional background was provided and it was stated that the patient was in ventricular fibrillation prior to use of the protekduo and they were unable to resolve it.The patient was put on support with the protekduo on nov 18, 2022 because their lvad was not doing well.Patient was very sick and was a status one patient with renal failure.A bypass surgery and heart transplant was conducted while on support with the protekduo and after the heart was removed, rather than doing another rvad insertion after placement of the transplant heart on nov 21, 2022, the decision was made to leave the protekduo in and worked around it by stitching the new heart to the already placed cannula so it could be reused post-transplant.This was not a conventional use of the protekduo and is considered off-label, as the device is intended to be used for rv support, not cardiopulmonary bypass.The customer essentially used the device twice and the second time was not through a normal placement.Dr.Pawale made a point to note that the cannula did its job twice in this case.No tricuspid regurgitation was noticed after patient came off bypass and the heart was inspected prior to placing and had no tricuspid regurgitation present.Only after removing the cannula a week later on nov 29, 2022 was the tricuspid regurgitation noticed, however dr.Pawale stated that even if it was noticed before removal, nothing differently would have been done.Ultimately, the physician involved with this case stated that this was an unconventional placement using direct visualization and no fluoroscopic imaging, and they believe the choice on how to place and subsequently use the cannula post-transplant put additional, unnoticed strain on the heart and resulted in the tricuspid regurgitation.Finally, dr.Pawale stated that the point of the article was not to indicate that the protekduo caused tricuspid regurgitation, but rather to highlight how to address it if it occurs.The physician stated that they have no change in opinion on the benefits of using the protekduo following this event.Dr.Pawale confirmed that the device was not saved and was immediately discarded post-explant, so it is not available for return to livanova for further investigation.The device sn is also unknown, so a review of the dhr could not be performed.Based on the details above, it was concluded that the reported event was not the result of a device malfunction, but rather a result of unconventional placement and off-label use of the device for this particular patient.No specific corrective actions have been identified for this event.If any additional information relevant to the reported event is received, h3 other text : device discarded by user.

Event Description

Livanova received a report through a literature review (2023, schumer et al.) which stated that a 44-year-old man on support with a protekduo 31fr cannula experienced severe tricuspid regurgitation (tr) with a flail leaflet causing moderate rv dilatation and mild rv dysfunction.The tr was found on the first surveillance transthoracic echocardiogram.This was managed conservatively with a plan to intervene after the patient recovered.One month post-transplant, the patient reportedly developed an enterobacter mediastinitis infection requiring multiple extensive debridements with an open chest for several weeks.The patient is doing well, 6 months after discharge to home, asymptomatic, without re-admissions, on renal recovery path, with no tricuspid regurgitation and good biventricular function.

Manufacturer Narrative

Submitted oct 31, 2023, was truncated.Final sentence should have stated: if any additional information relevant 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): CARDIAC ASSIST INC.; 620 alpha dr; pittsburgh PA 15238
• Manufacturer (Section G): CARDIAC ASSIST INC.; cardiac assist inc.; pittsburgh PA 15238
• Manufacturer Contact: ryan coyle ; 620 alpha dr.; pittsburgh, PA 15238
• MDR Report Key: 18040310
• MDR Text Key: 326980516
• Report Number: 2531527-2023-00032
• 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: 10/31/2023

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
• Device Model Number: 5140-5131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/31/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/31/2023
• 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
• Patient Age: 44 YR
• Patient Sex: Male