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

Model Number 5140-5131

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Ischemia (1942); Pneumonia (2011); Septic Shock (2068); Respiratory Failure (2484); Multiple Organ Failure (3261); Hemorrhagic Stroke (4417); Ischemia Stroke (4418); Thrombosis/Thrombus (4440); Respiratory Arrest (4461); Renal Impairment (4499)

Event Type  Death  

Event Description

From a literature review.Saaed, stein et al.2021 report on a multicenter, retrospective cohort study of patients aged =18 years who were placed on ecmo anytime between march 1, 2020, and april 30, 2021.The cohort of 435 patients from 17 centers was divided into the following three groups based on the initial v-v ecmo cannulation method: (1) femoral vein- femoral vein or femoral vein-internal jugular vein (dual-site, c-ds; 247 patients) (2) single, dual-lumen cannula in internal jugular vein with tip positioned in the pulmonary artery (c- pa; protek duo, livanova; 99 patients) (3) single, dual- lumen cannula in internal jugular vein advanced through the svc into the right atrium with tip positioned in the ivc (c- ivc; crescent, medtronic, or avalon, avalon laboratories; 89 patients).Specific to the c-pa cohort: 59% survival to hospital discharge; complications included bacterial pneumonia 33% (33/99), bacteremia 49% (48); deep vein thrombosis 12% (11/99), ischemic stroke 3% (3/99), hemorrhagic stroke (14% (14/99), and limb ischemia 4% (4/99), bleeding requiring transfusion 88% (73/99), and renal replacement therapy 50% (41/99).The authors concluded that catheter-directed flow into the pa bypassing the right ventricle with a single dual-lumen cannula (c-pa) is associated with reduced in-hospital mortality during v-v ecmo for covid-19 in comparison to dual-site cannulation.38/99 patients expired on ecmo.Causes of death for the group with protekduo included: hemorrhagic shock (1/99), multi-organ failure (20/99); respiratory failure (2/99), septic shock (6/99), stroke (8/99) and other cause of death (2/99).Protek duo cannula size was not specified.The study was multicenter, therefore specific hospital(s) where events occurred was not specified.

Manufacturer Narrative

Device disposable discarded.

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.B.2.Updated to add "required intervention" and "other serious" to list of adverse events along with "death".B.5.Event description was re-written from initial report to more clearly summarize the reported event.D.4.While part number 5140-5131 was included in the initial report, the literature did not specify the specific size of protekduo used.G.4.While 510k number k160257 was included in the initial report, the literature did not specify the specific size of protekduo used.H.3.Initial report indicated device was discarded, however this is not known.H.6.Codes were inadvertently left blank in initial report.H.10.Livanova manufactures the protekduo cannula.The incident occurred in the united states across multiple facilities.Exact hospitals are not known at this time.This event is being filed in response to discovery of literature detailing adverse events and deaths during procedures utilizing the protekduo cannula.However, there was no reported device malfunction and no specific allegation was made that the protekduo was the cause of any of the reported events.As no specific details about each event was provided, a single report is being filed to document the details of this literature review.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.H3 other text : hospitals and device sns not provided, unknown if available for return.

Event Description

From a literature review conducted on july 5, 2022, livanova identified a report (saaed, stein et al.2021) regarding a group of patients aged 18 years or older who were placed on ecmo between march 1, 2020 and april 30, 2021.This group consisted of 435 patients across 17 different facilities, who were separated into the following 3 groups based on the cannulation method: (1) femoral vein- femoral vein or femoral vein-internal jugular vein (dual-site, c-ds; 247 patients) (2) single, dual-lumen cannula in internal jugular vein with tip positioned in the pulmonary artery (c- pa; protekduo, livanova; 99 patients) (3) single, dual- lumen cannula in internal jugular vein advanced through the svc into the right atrium with tip positioned in the ivc (c- ivc; crescent, medtronic, or avalon, avalon laboratories; 89 patients).The literature indicated that patients in the second group utilizing the livanova protekduo device (size not specified) experienced a survival rate of 59%, with complications ranging from bleeding requiring transfusion (73 patients) bacteremia (48 patients), renal replacement therapy (41 patients), bacterial pneumonia (33 patients), hemorrhagic stroke (14 patients), deep vein thrombosis (11 patients), limb ischemia (4) patients) and ischemic stroke (3 patients).Of these patients, there were 39 deaths due to complications including multi-organ failure (20), stroke (8), septic shock (6), respiratory failure (2), hemorrhagic shock (1) and other cause of death (2).The literature did not identify a link between use of the protekduo and the adverse events or deaths, but concluded that use of the single dual-lumen protekduo cannula was associated with a reduced in-hospital mortality rate during v-v ecmo for covid-19 patients in comparison to dual-site cannulation.No specific device malfunction was reported.

• 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 ; 2812287200
• MDR Report Key: 15158154
• MDR Text Key: 297172366
• Report Number: 2531527-2022-00036
• 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
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

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
• Device Catalogue Number: 5140-5131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: 07/05/2022
• Supplement Dates FDA Received: 08/03/2022
• 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; Death; Required Intervention