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

Model Number 5140-5131

Device Problem Positioning Failure (1158)

Patient Problem Cardiac Tamponade (2226)

Event Date 10/08/2023

Event Type  Death  

Manufacturer Narrative

A1., a2., a4.-a6.Patient identifier, age, weight, ethnicity and race were not provided.B2.While the patient died, there is currently no allegation or evidence that the death was caused in any way by the use of the protekduo cannula.The customer stated that they do not attribute the adverse events or patient outcome to any malfunction of the protekduo or other livanova device.While the cannula did migrate into the rv tract, the physician determined that adequate support was being provided and made a decision to leave it in place, and no other specific malfunction of the protekduo has been identified.The customer believes the patient experienced a pulmonary embolism that caused her to seize, and stated that the protekduo fully migrated into the rv only upon initiation of cpr with the lucas device.The death was the result of the pulmonary embolism and subsequent seizure and is not believed to be related to the cannula migration.D4.Device serial number was not available, so udi and expiration date could not be determined.H4.Device serial number was no provided, so manufacture date is unknown.H10.Livanova manufactures the protekduo cannula.The event occurred in torrance, california.The cannula was discarded and was not made available for evaluation.Although a device evaluation could not be conducted, follow-up communication was performed and additional details were provided by the customer.The customer stated that they were not performing regular daily x-rays or daily centimeter checks, as they wanted to reduce radiation exposure and the dressing prevented inspection of the insertion site.Instead, they were doing these checks every 3-4 days.Anticoagulation had also been stopped as the patient was experiencing a nasal bleed unrelated to the device.They were running therapeutic ptts low in the 40 range prior to stopping use.On october 8, the patient seized and started foaming at the mouth.According to the physician and pa, the lifesparc flows remained constant at this time.The team initiated cpr with a lucas device and the critical care physician got a tte and noticed a moderate tamponade.The physician drained approximately 600ccs, and flows at this time were starting to diminish and fluctuate.According to the ct surgeon, no more tamponade was seen after the initial 600cc was drained.It was stated that the lucas device was quite aggressive and also shifted and had to be placed back in the median sternum.Flows never returned other than brief moments of approximately 0.8-1.8 lpm, possibly due to suction events with the lucas device providing brief periods of suction and release from the drainage basket.Following the event, it was determined the patient had minimal brain function and her arterial blood was dark from sampling.The family decided to place the patient on comfort care and she passed.When the cannula was removed (approximately 45-60 min post code), a large clot was identified in the distal tip extending outside of the cannula.The customer stated that none of these events were directly related to the function of any livanova device.The customer also stated that the protekduo could have migrated into the rv upon initiation of cpr with the lucas device, but did not believe this occurred prior to the seizure event.The physicians stated that they do not attribute the adverse events or patient outcome to any malfunction of the protekduo or other livanova device.While the cannula migrated into the rv tract, the physician determined adequate support was being provided and made a decision to leave it in place, and no other specific malfunction of the protekduo has been identified.The customer believes the patient experienced a pulmonary embolism that caused her to seize, and stated that the protekduo fully migrated into the rv only upon initiation of cpr with the lucas device.A dhr review could not be completed, as the device serial number was not made available.As a device evaluation could not be performed and troubleshooting was not performed by the customer, an exact root cause for the cannula migration could not be determined.However, the prolonged use of the cannula of roughly 60 days could have contributed to the event.The protekduo directions for use indicate: ¿the tandem heart system has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.E., longer than 30 days) as a bridge to transplant, for pending recovery of the natural heart, or extracorporeal membrane oxygenation (ecmo)¿ and ¿the use of this device for periods longer than 30 days increases the risk of pump failure, reduced pumping capability, excessive blood trauma, degradation and/or corrosion of the blood contacting materials (with the possibility of the particles passing through the cpb circuit to the patient), leaks, and increased potential for gaseous emboli entering the arterial line.¿ in addition to the above, the decision to leave the protekduo in place following discovery that it had been migrated into the rv tract was a clinical decision and not based on instruction outlined in the directions for use.With that said, it is not believed by livanova or the customer that this migration event was the cause of the pulmonary embolism, seizure or death.As no exact root cause has been determined, corrective actions were not identified.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report that a protekduo 31fr cannula experienced a migration from the pa into the rv tract during support.After roughly 60 days of use, the patient was ambulating and doing daily laps around the unit.On (b)(6) 2023, the patient reported chest pain and an x-ray revealed the protekduo had migrated into the rv tract.The patient was being adequately supported so the decision was made to leave the device in place.During a bath on october 8, 2023, the patient lifted her arms above her head and immediately decompensated.An echo taken at that time revealed a large tamponade and 600ccs were drained.The protekduo was removed and the patient was converted to v-va ecmo, however brain function was determined to be minimal and the patient expired after being moved to comfort care.While the patient died, there is currently no allegation or evidence that the death was caused in any way by the use of the protekduo cannula.

• Brand Name: PROTEK DUO VENO-VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIAC ASSIST INC.; 620 alpha dr.; pittsburgh PA 15238
• Manufacturer (Section G): CARDIAC ASSIST INC.; 620 alpha dr.; pittsburgh PA 15238
• Manufacturer Contact: ryan coyle ; 620 alpha dr.; pittsburgh, PA 15238
• MDR Report Key: 18066988
• MDR Text Key: 327308198
• Report Number: 2531527-2023-00033
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2023

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: 10/09/2023
• Initial Date FDA Received: 11/03/2023
• 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 Sex: Female