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

Model Number 5140-4629

Device Problem Migration (4003)

Patient Problems Ulcer (2274); Cardiac Perforation (2513)

Event Date 01/24/2022

Event Type  Death  

Event Description

Livanova received report that patient died about 24 hours after the implantation date of a protekduo 29 fr cannula.Reportedly, the positioning phase and the first 24 hours after went well without any problems encountered.The flow was 2l /min with good hemodynamics and a pressure of 130.After about 24 hours, the patient died and the autopsy found that the cannula created decubitus ulcer on the lung wall leading to tamponade.The cannula was positioned about 4cm from the valve plane and it was found a displacement of about 1cm.

Manufacturer Narrative

Patient information was not provided.Cardiacassist inc.Manufactures the protek duo veno-venous cannula.The incident occurred in (b)(6).Through follow-up communication livanova learned that the cannula was connected to a right ecmo with centrifuge and oxygenator.It was the first implant in the center and there was no tandemlife specialist to support the case.In addition, it was learned that the cannula was fixed with suture wings in the jugular area of insertion.An angiography check was done at the end of the insertion phase and the positioning was good.The cannula was fully inserted (abutment) and the distal part was just above the valve plane.The patient had the right section dilated and this according to the clinician's hypothesis had "stolen" length from the cannula (in fact it indicates that it would have been necessary to have a longer cannula).After cannula placement, the patient was moved to intensive care.In the late morning, a few hours after implantation in intensive care, the patient developed a hematoma in the neck in the left contralateral jugular where the anesthetist had stung to insert the venous cannula for the infusion of drugs, therefore not in the protekduo cannula site.To prevent that the hematoma would compress the trachea, the customer decided to intubate him.The intubation maneuver involves stretching the neck backwards and the clinician hypothesizes that this maneuver may have dislodged the protekduo from its original position.It was communicated that upon cannula removal, no defect/damage of the cannula could be noticed by the customer.Based on information currently available, no defect/damage of the cannula could be identified thus the reported migration is not related to any malfunction of protekduo.In addition, on the basis of clinician's opinion, the most likely root cause of the cannula dislodgment is attributable to neck maneuvers conducted during patient intubation and therefore not related to any cannula malfunction.

Manufacturer Narrative

Patient information was not provided.Cardiacassist inc.Manufactures the protek duo veno-venous cannula.The incident occurred in (b)(6).Through follow-up communication livanova learned that the cannula was connected to a right ecmo with centrifuge and oxygenator.It was the first implant in the center and there was no tandemlife specialist to support the case.In addition, it was learned that the cannula was fixed with suture wings in the jugular area of insertion.An angiography check was done at the end of the insertion phase and the positioning was good.The cannula was fully inserted (abutment) and the distal part was just above the valve plane.The patient had the right section dilated and this according to the clinician's hypothesis had "stolen" length from the cannula (in fact it indicates that it would have been necessary to have a longer cannula).After cannula placement, the patient was moved to intensive care.In the late morning, a few hours after implantation in intensive care, the patient developed a hematoma in the neck in the left contralateral jugular where the anesthetist had stung to insert the venous cannula for the infusion of drugs, therefore not in the protekduo cannula site.To prevent that the hematoma would compress the trachea, the customer decided to intubate him.The intubation maneuver involves stretching the neck backwards and the clinician hypothesizes that this maneuver may have dislodged the protekduo from its original position.It was communicated that upon cannula removal, no defect/damage of the cannula could be noticed by the customer.Based on information currently available, no defect/damage of the cannula could be identified thus the reported migration is not related to any malfunction of protekduo.In addition, on the basis of clinician's opinion, the most likely root cause of the cannula dislodgment is attributable to neck maneuvers conducted during patient intubation and therefore not related to any cannula malfunction.

Event Description

Livanova received report that patient died about 24 hours after the implantation date of a protekduo 29 fr cannula.Reportedly, the positioning phase and the first 24 hours after went well without any problems encountered.The flow was 2l /min with good hemodynamics and a pressure of 130.After about 24 hours, the patient died and the autopsy found that the cannula created decubitus ulcer on the lung wall leading to tamponade.The cannula was positioned about 4cm from the valve plane and it was found a displacement of about 1cm.

Event Description

See initial report.

Manufacturer Narrative

H.10: a medical assessment of the event has been conducted.Outcome of the assessment is that even if the cannula is correctly positioned and correctly sutured with wings, the cannula can be moved during the intubation procedure.Thus, medical assessment confirmed what was reported by the customer and that the reported event was caused by neck maneuvers conducted during patient intubation and therefore not related to any cannula malfunction.In addition, no cannula defect could be noticed upon removal.

Event Description

See initial report.

Manufacturer Narrative

H.10: livanova received notification of the event from italian ministry of health.Information about event date could be identified.Event date has been added to the dedicated b section.In addition, it was stated that during cannula use, a perforation of the right ventricle happened with consequent acute cardiac tamponade.

• 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: enrico greco ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 13599400
• MDR Text Key: 286124132
• Report Number: 2531527-2022-00018
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K160257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2022

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: 5140-4629
• Device Catalogue Number: 5140-4629
• Device Lot Number: 291970
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/25/2022
• Supplement Dates Manufacturer Received: 03/08/2022; 06/24/2022
• Supplement Dates FDA Received: 04/07/2022; 07/21/2022
• 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): Death