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

Model Number 5140-5131

Device Problem Obstruction of Flow (2423)

Patient Problems Hemolysis (1886); Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

Through a literature review, livanova became aware of an article entitled "intracannula thrombus formation associated with dual lumen protekduo cannula in extracorporeal membrane oxygenation" (january 2023, spelde et al.) ) which described a 29-year-old female patient suffering from covid-19 who required intubation upon admission.Despite treatment with proning, paralysis and ultra-low stretch mechanical ventilation, the patient reportedly exhibited minimal recovery of lung function.Twenty days after initial cannulation, she was converted to a 31fr right ij protekduo with ra inflow and pa outflow to assist with rehabilitation.An additional 25fr multistage femoral inflow cannula was added 3 days later given inability to maintain adequate flows.Systemic anticoagulation was held for 23 days after protekduo placement due to ongoing airway bleeding and procedures including tracheostomy and chest tube placement.Severe hemolysis prompted conversion back to femoral-femoral vv ecmo with 25fr multistage inflow and 22fr single stage outflow 29 days after protekduo placement.At removal, thrombus was noted in the protekduo inflow, thought to be the source of hemolysis.Acute rv dysfunction followed removal of protekduo rv support.Placement of another oxygenated right ventricular assist device (oxy-rvad) was planned; however, the patient was noted to have superior vena cava (svc) syndrome due to svc/ra thrombus that had formed around the prior protekduo cannula.Patient went on to successfully rehabilitate and underwent bilateral lung transplantation 95 days after initial cannulation.

Manufacturer Narrative

Patient information not provided.Event date was not provided.Serial number was not provided, so udi number and expiration date could not be determined.Hospital information has not been provided.Manufacturing date is unknown, as the serial number has not been provided.Livanova manufactures the protekduo 31fr cannula.The incident occurred in the united states.An exact hospital is not known at this time.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device availability for return is unknown.

Manufacturer Narrative

D9: device not available for return.E1: hospital information and contact information was provided.H10.Through follow up communication with one of the authors of the article (dr.(b)(6)), livanova learned that the device was not available for return, so a device evaluation could not be performed.Dr.(b)(6) reported that the patient experienced systemic hemolysis as a result of thrombus in her cannula, which resulted in a change in her ecmo platform.She stated that this was not considered a device malfunction but rather a complication potentially related to patient conditions (covid associated respiratory failure and coagulation).During additional follow-up was performed with another co-author (dr.((b)(6)), it was clarified that the use case was an extreme exception to typical cannulation configurations.The protekduo was being used off label during this case, with a femoral drain like an rvad and vv ecmo together, because of the severe patient condition.Dr.(b)(6) also stated that anti-coagulation therapy was difficult to maneuver and due to the patient population at this facility, this situation does not compare to other use cases.Dr.(b)(6) indicated that this was not intended to be a complaint or report of malfunction and patient condition was an overwhelming factor along with the cannula size and dilator size chosen at the time of cannulation in relevance to the patients arteries.Given the patient condition and the nature of therapy, the authors indicated that there was no malfunction of the device and the clotting and svc syndrome were both functions of the patient condition (covid) and procedural methodology (decisions on anticoagulation, size of cannula compared to patient vein) as opposed to a device failure.As such, this event has been re-assessed as non-reportable.

• 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: 16773217
• MDR Text Key: 313629920
• Report Number: 2531527-2023-00008
• 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: 05/19/2023

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: 03/06/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 04/25/2023
• Supplement Dates FDA Received: 05/19/2023
• 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; Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female