MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 201-90010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Renal Failure (2041); Shock (2072); Thromboembolism (2654); Thrombosis/Thrombus (4440); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 03/02/2021

Event Type  Injury  

Event Description

It was reported that the patient expired due to hemorrhagic shock on (b)(6) 2021 following pump implant on (b)(6) 2021.The outcome was not device or therapy related.No autopsy was performed.The device was explanted.The device will not be returned for evaluation.Privacy laws prohibit the customer from providing information regarding the case.The patient had a history of coronary artery bypass graft (cabg) 10 years prior to the event (left internal mammary artery (lima)- left anterior descending artery (lad), right internal mammary artery (rima) right carotid artery (rca), saphenous vein graft - obtuse marginal artery (svg-om)).Lima and rima grafts were patented by the account.The patient's aortic valve was bicuspid valve.Pulmonary vascular resistance (pvr) was 9.6 woods unit.The patient was dependent on adrenaline for more than 10 to 15 days prior to the event.The patient had undergone bi-femoral embolectomy.The patient's white blood cell (wbc) count was high before the week of implant.The patient's wbc count reduced from 30,000 to 12,000 pre-implant.The patient's bilirubin was high at 2.6 and the patient had an international normalized ratio (inr) of 1.4.Serum creatinine was 3.0 which reduced to 1.9.The patient had bilateral renal artery stenosis.Central venous pressure (cvp) was 19 mmhg.Pulmonary artery (pa) pressures were 80 mmhg.The patient underwent bilateral stenting on (b)(6) 2021.The patient was listed for heart and lung transplantation.The organs were not available during the patient's hospitalization.Due to the patient's dependency on inotropes and unavailability of organs, the account implanted a heartmate 3 as bridge to transplant.The patient was implanted with a heartmate 3 on (b)(6) 2021.Peripheral cardiopulmonary bypass (cpb) was conducted.Many adhesions were noted during sternotomy.The patient required right ventricular centrimag support following the heartmate 3 implant.The patient had severe bleeding following implants.The patient's chest could not be closed.The patient developed disseminated intravascular coagulation (dic).The patient was shifted to the intensive care unit with only a skin close after nearly 22 hours of patient wheeled in.The patient had no urine output while on cardiopulmonary bypass (cpb).The patient required continuous renal replacement therapy (crrt) in the operating theatre (ot).Extensive efforts were made to control bleeding, including treating with blood and blood products.The patient had low flows due to hemorrhagic shock.The patient continued heavily bleeding from the heart while in the icu.After a period of time, the patient's blood flow reduced.The patient developed cardiac arrest and could not be resuscitated.The heartmate 3 surgery was a redo surgery.Aortic valve replacement was done due to aortic regurgitation with 21 mm epic valve.Left atrial appendage was small.The left atrium was opened but the clot could not be taken out as it was densely attached to the left atrium.Peripheral cpb conducted.Femoral vein 23 fr.Axially cannula was grafted with 8 fr graft.24fr eopa cannula was inserted for cpb support.Fv catheter was used for draining.8 fr graft was inserted in to the pulmonary graft.22 fr eopa catheter was inserted into graft.The bi-femoral embolectomy was prior to the left ventricular assist device (lvad) implant.There was no device-related issue that caused or contributed to the right heart failure.The patient had right heart failure before the lvad implant.The device operated as expected.The bi-femoral embolectomy was performed approximately 10 days before the lvad implant.The blood pump was not to be returned.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the reported events, including the patient outcome, and the centrimag device could not be determined through this evaluation.It was reported that the centrimag blood pump would not be returned for evaluation.The ous centrimag blood pump instructions for use (ifu) lists bleeding, renal dysfunction, and death as adverse events that may be associated with the centrimag circulatory support system under ¿adverse events¿.This ifu also provides the following warnings and cautions: ifu warning #7: it is intended that systemic anticoagulation be utilized while this device is in use.Anticoagulation levels should be determined by the physician based on risks and benefits to the patient.Ifu warning #10: frequent patient and device monitoring is recommended.Ifu warning #15: monitor the patient¿s hemodynamics and the console flow display to ensure adequate blood volume for the inlet cannula position, pump rpm, and desired flow.Increase the pump rpm in small increments to minimize the risk of exceeding the available blood volume and causing inlet cannula obstruction, suction, outgassing, and/or cavitation.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.Furthermore, the ifu states that, ¿actual obtainable flow is dependent on the difference between the preload and afterload of the pump (pump pressure differential, the resistance to flow through the extracorporeal circuit components (cannulas, tubing, etc.) and the patient hemodynamics (intravascular pressures, cardiac output, and available volume)¿ under ¿pressure vs flow graph¿.Review of the device history record (dhr) for the centrimag blood pump (dhr cm pump l06852-la3) revealed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Related manufacturer reference number: (b)(4).

• Brand Name: CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 11531638
• MDR Text Key: 241129179
• Report Number: 3003306248-2021-01082
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 07640135140627
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

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 Operator: Health Professional
• Device Expiration Date: 09/23/2023
• Device Model Number: 201-90010
• Device Catalogue Number: 102953
• Device Lot Number: L06852-LA3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2021
• Initial Date FDA Received: 03/19/2021
• Supplement Dates Manufacturer Received: 06/14/2021
• Supplement Dates FDA Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Required Intervention