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

Model Number 5140-5131

Device Problem Migration (4003)

Patient Problem Cardiac Perforation (2513)

Event Type  Death  

Manufacturer Narrative

A1., a4.-a6.Patient identifier, weight, ethnicity and race were not provided.B2.Date of death has not been provided.B3.Event date has not been provided.D4.Device lot number is not available, so the expiration date and udi number could not be determined.H4.As the lot number is not available, manufacture date could not be determined.H10.Livanova manufactures the protekduo device.The reported event occurred in (b)(6), michigan.A livanova medical affairs expert was able to speak with dr.(b)(6) on the phone.Dr.(b)(6)reported that there was no specific malfunction to report in relation to this event.The cannula was reportedly secured to the patient in the 3 suture orientation per the institutional protocol on each bifurcation arm plus at the hard plasticy to neck / scalp.Dr.(b)(6) reported that the event occurred in week 3 of patient support while the patient was being treated for a refractory cough which was unresponsive to tussive therapies.The cough necessitated titration of sedation, and coughing fits likely provoked an acute change in intrathoracic pressures, causing cannula retrograde migration, ultimately leading to free wall perforation.Dr.(b)(6) indicated that the protekduo cannula performed as intended.The event date and serial number were not able to be provided, and the device was not available for return to livanova for evaluation.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 and the event and patient death were the result of patient condition (covid-19, acute hypoxic respiratory failure and refractory cough) 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 not available for return.

Event Description

During a literature review, livanova identified an article (freny sebastian et al., 2023) which described a 32-year-old male patient with no past medical history who presented with shortness of breath.The patient was diagnosed with covid-19 pneumonia, which led to acute hypoxic respiratory failure and required intubation.The patient was cannulated for vv ecmo via the right internal jugular approach with a 31fr protekduo dual lumen cannula to a tandemlung oxygenator and lifesparc pump.In the days before decannulation, the patient started coughing and suddenly developed cyanosis from the neck up, followed by pulseless electrical activity (pea) cardiac arrest.Cardiopulmonary resuscitation (cpr) was initiated, and the pump was turned down.There were no issues with the oxygenator or pump.The patient expired and a post-mortem autopsy revealed right ventricular perforation by the protekduo cannula.The cannula had to be re-secured earlier that night, as it had migrated back.Thy physician noted that it likely fell into the right ventricle when the patient was coughing with severe intrathoracic pressure changes, causing a perforated rv-free wall.

• 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: 17476721
• MDR Text Key: 320563799
• Report Number: 2531527-2023-00022
• 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: 07/10/2023

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: Not provided
• 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): Death
• Patient Age: 32 YR
• Patient Sex: Male