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

Catalog Number 5140-4629

Device Problems Positioning Failure (1158); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 07/27/2021

Event Type  Injury  

Manufacturer Narrative

H10.Livanova manufactures the protekduo cannula.The reported event occurred in (b)(6).Livanova was able to contact several of the authors of the article, dr.Syed haq and dr.Sandeep patel, to discuss the literature.During this follow-up communication, it was reported that there was no structural malfunction associated with the protekduo cannula.It was stated that cannula malposition is a risk regardless of the cannula type and the patient anatomy and vascular tortuosity can contribute to an increased risk of malposition or migration.The immediate nature of the patient hemodynamics at the time of the event made time a factor, so the user opted for repositioning to establish the circuit and prevent rhf.Once the cannula tip was repositioned, the circuit was a success.Dr.Haq reported that the patient eventually passed, however this patient outcome was reportedly related to pre-existing conditions and complications with covid-19 ards and vali after prolonged duration of ecmo, and was not related to the cannula migration event.The patient was reportedly on support for about 1 hour before the migration event occurred.The device serial number was not able to be provided, and the device was not available for return to livanova for evaluation.As such, a more detailed device evaluation was not possible and a review of the dhr could not be performed.Based on the information provided by the physician involved with the reported event, it can be concluded that there was no specific device malfunction which occurred.Through a review of historical complaints for similar issues, it was found that cannula migration occurrences are often not related to a device malfunction and depend on external factors such as cannula deformation and migration due to patient movements and/or accidental movement of the device by the users and/or the cannula not being correctly secured to the patient.As stated by the authors of the article, the patient death outcome was the result of patient condition (covid-19, ards) rather than a malfunction of the protekduo.As there is no specific device malfunction identified and the device is not available for evaluation, no further investigation is possible and no corrective actions have been identified.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.H3 other text : device discarded by customer.

Event Description

Through a literature review (nov 2023, syed h.Haq et al), livanova learned of an adverse event related to migration of the protekduo cannula.The literature described a previously healthy 31-year-old caucasian male who was admitted with covid-19 pneumonia.The patient rapidly decompensated, resulting in severe hypoxia, and was subsequently intubated.Imaging and pao2:fio2 ratios were consistent with acute respiratory distress syndrome.Because of high ventilatory pressures and an inability to maintain adequate oxygenation, veno-venous extracorporeal membrane oxygenation (vv-ecmo) was pursued.A transesophageal echocardiogram [tee] demonstrated no major valvulopathies with an estimated ejection fraction of 55% to 60%.Per institutional protocol during the covid-19 pandemic, the cannula of choice was the protekduo.Right internal jugular access was obtained and a 29fr protekduo catheter was inserted under fluoroscopic and tee guidance.The cannula was situated above the pv toward the right pa but primarily at the bifurcation of the pa.The system was slowly ramped up from 3,500 to 6,000rpm with flows around 4.5 to 5.0lpm.While suturing the cannula in place, the flowrate dropped precipitously with oxygen saturation around 75% to 80%.On tee, no effusion or signs of left heart failure were visualized, however the cannula had reportedly migrated proximal to the pv, lying anteriorly on the right ventricular outflow tract free wall.Due to rapid deterioration, disconnecting the ecmo circuit to re-cannulate the patient was not a consideration.Therefore, staff improvised a novel method of using a gooseneck snare to correct the positioning of the cannula.

• 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: 18311986
• MDR Text Key: 330293370
• Report Number: 2531527-2023-00040
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2023

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 Catalogue Number: 5140-4629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/12/2023
• 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): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White