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

Model Number 5140-5131

Device Problem Unintended Movement (3026)

Patient Problem Cardiac Perforation (2513)

Event Date 12/02/2021

Event Type  Death  

Event Description

Livanova received a report related to patient who was cannulated with protek duo 31 french and was extubated.Patient was experiencing coughing spells.Patient coughed and then coded.Unsuccessfully tried to revive the patient.

Manufacturer Narrative

Through follow-up communication with np/ecmo coordinator on (b)(6), it was reported that: "covid 19+ patient cannulated with 31 fr protekduo on (b)(6).Livanova personnel was present during the cannulation procedure.Patient initiated on 31fr protekduo with lifesparc pump and in series oxygenators.Cannula distal tip position confirmed with fluoro.No specific echo determinations made during initial cannulation as typical procedure for that customer.Suture wings not used to secure cannula to patient.Looped sutures secured cannula to patient at skin site.Another suture to the rt ear of pt and another suture to tubing looped over pts head and secured to pts left shoulder.Cannula depth noted at insertion and regularly checked by icu care team.There was no cannula migration ever at insertion site according to np ecmo coordinator.Pt was extubated, awake and both sitting up and walking in the unit.He was experiencing coughing episodes on and off throughout the support run.On (b)(6) staff decided to move pt to another room to ¿give him a different view.¿ prior to moving pt, sutures were changed.This is a standard practice at the site if moving pts to another room.They also changed the circuit to a cardiohelp prior to moving him.During the run, echo was performed every day and then moved to every 3 days.I asked if the echo was ever used to determine distal tip depth of pd and was told no, they only do the echo to determine rv function.Daily x-ray was also done.Told they used the x-ray to look for the classic ¿u¿ shape of the cannula to confirm proper position.An x-ray was also performed the evening of (b)(6) at 7:30 pm to confirm placement prior to moving pt to new room.Placement looked good on the x-ray according to the staff.At approx.2:30 am on (b)(6), pt was awake and sitting up talking with the ecmo specialist when he started to experience another coughing episode.During this episode, he said ¿ouch¿ and reached for his side or hand (not fully clear on what he reached for) and immediately slumped over and coded.Team responded to the code and provided cpr for approximately 30 minutes before calling the resuscitation efforts off.Rpms were lowered at start of cpr and they lost flow shortly after code.Autopsy later determined the distal tip of the pd cannula had perforated the rv." livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H.10: on february 14, 2022 livanova received a medwatch report from fda regarding this event.Within the report issued by the customer, it was stated that a check of positioning after any possible manipulation is conducted.This is not fully in accordance with what declared by np/ecmo coordinator who stated that cannula position was checked after cannula was re-sutured and not after patient being moved to the other room.In addition, within the report it was stated that patient was morbidly obese as pre-existing condition which may have contributed to the event.A medical assessment of the reported case was conducted.Following points from follow up with np/ecmo coordinator were highlighted: - cannula migration is a inherent risk of the procedure - patient was experiencing coughing episodes on and off throughout the support run (from (b)(6) 2021 to (b)(6) 2021).- suture wings were not used.- medical staff of the customer facility confirmed that no cannula migration occurred prior decision to move patient to another room.- the cannula was re-sutured prior patient being moved to the other room.- the cannula position was check by x-ray prior patient being moved to the other room and not declared to have been done following move to other room.- cannula positioning was checked with x-ray only and echocardiography was not used as reported in device instruction for use to check positioning (depht of cannula).As per instruction for use: "confirm the protekduoveno-venous cannula position assuring that the cannula tip is in the desired position.The following methods may be employed to confirm position: a.Using fluoroscopy, confirm that the end of the wire-reinforced section of ¿distal¿ cannula & cannula tip is positioned properly.B.Use transthoracic echocardiography for proper positioning." - the patient was eventually moved to the other room.- on (b)(6) 2021 the patient started to experience another coughing episode and following to that patient coded and cpr was administered for 30 minutes.- obesity of the patient can be a contributing factor to the reported event, as per statement of the customer in the medwatch report, since the position of the cannula may be difficult to detect precisely in case x-ray is the only method used verify cannula positioning.Result of the medical assessment is that multiple factors such as patient being moved to another room, coughing episodes, cannula positioning check tecniques (x-ray), sutures and patient obesisty pre-existing condition may have contributed to the reported event.None of the above mentioned elements points to any specific device related issue.Livanova reasonably concludes that the reported event associated to the cannula use was caused by the above mentioned factors and is not related to any device malfunction.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• 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: 13109961
• MDR Text Key: 282906830
• Report Number: 2531527-2021-00054
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

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 Model Number: 5140-5131
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 01/25/2022
• Supplement Dates FDA Received: 02/23/2022
• 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