MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 103695

Device Problems Mechanical Problem (1384); Obstruction of Flow (2423); Infusion or Flow Problem (2964); Naturally Worn (2988)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 01/25/2022

Event Type  Injury  

Event Description

It was reported that the patient was admitted for pump thrombus.The patient contacted ventricular assist device (vad) coordinators after noticing a change in flow and pulsatility index (pi) in addition to urine color changing from yellow to dark amber with no change in hydration status.The were no noted changes to patient anticoagulation status or pump parameters that would have contributed.An echocardiogram was performed and noted normal peak inflow velocities.The aortic valve opened with every beat and the patient had an ejection fraction (ef) of 10-15%.The intraventricular septum bowed from left to right.A computed tomography (ct) scan was done to assess the outflow graft and a nonocclusive thrombus was noted.The patient was admitted for anticoagulation and workup.Pump function marginally improved with intravenous (iv) bivalirudin, increased international normalized ratio (inr) goal, and high does aspirin.The patient presented to the interdisciplinary committee and was deemed not a candidate for pump exchange.As the patient was receiving adequate support from the vad with stable parameters and no alarms.The patient was discharged home with referral for transplant or high risk pump exchange evaluation.Prior to discharge, the patient was noted to have exposed wires in their driveline.Log file review did not capture any unusual events but there was a shift in pump power from high 6's and 7 watts to the 5 watt range around (b)(6) 2022.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the submitted photos confirmed superficial driveline damage; however, a specific cause for this finding could not be conclusively determined through this evaluation.The report of a non-occlusive thrombus in the outflow graft was unable to be confirmed as no photos were submitted and the device is not available for evaluation.A direct correlation between heartmate ii left ventricular assist system (lvas), serial number (b)(6), and the reported events could not be conclusively established through this evaluation.The submitted driveline photos were reviewed and demonstrated external, superficial driveline damage.The bionate layer was visible from a tear in the driveline jacket approximately equidistance from the driveline exit site and the controller connector.Most of the external driveline was covered in rescue tape.The wires of the driveline were not visible, and there did not appear to be a driveline wire compromise.A review of the submitted log file found that the pump maintained a stable speed above the low speed limit without issue.Power and estimated flow appeared to decrease on (b)(6) 2022 from an average of approximately 6.8 w (watts) and 5.5 lpm (liters per minute), respectively, to an average of approximately 5.8 w and 4.0 lpm, respectively.The system appeared to be operating as intended, and there were no notable alarms active in the log file.The patient ultimately underwent a pump exchange on (b)(6) 2022 due to thrombus (captured under mfr.Report # 2916596-2022-10305).No product was received for this evaluation.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu), rev.C, is currently available.Section 1 ¿introduction¿ of this document lists device thrombosis as an adverse event that may be associated with the use of heartmate ii lvas.Additionally, section 6 ¿patient care and management¿ (under "pump performance monitoring") outlines indications of pump thrombosis as well as how to respond to such events.This section (under "anticoagulation") also contains information regarding the recommended anticoagulation therapy and inr (international normalized ratio) range.The ifu provides an explanation of each of the pump parameters, including pump power and flow, in sections 1 and 4 "system monitor".Section 1 (under "explanation of parameters") explains that device power is a direct measurement of pump motor voltage and current.Changes in pump speed, flow, or physiological demand can affect pump power.Abrupt changes in power should be evaluated for cause.In addition, device flow and power generally retain a linear relationship at a given speed.However, while power is directly measured by the system controller, the reported flow is estimated, based on power.Since the flow displayed on the system controller is a calculated value, it becomes imprecise at the low and high ends of the linear power-flow relationship.Section 4 cautions that no single parameter is a surrogate for monitoring the clinical status of the patient, and the changes in all parameters should be considered when assessing any clinical situation.Section 6 (under "pump performance monitoring") addresses assessing pump flow and explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.Section 6 of the ifu discusses damage due to wear and fatigue of the driveline.This section also contains information on ¿caring for the driveline¿ (under ¿ongoing system assessment and care¿) and provides possible indications of driveline damage as well as how to respond to such events.This section also instructs to check the driveline daily for signs of damage, such as cuts, holes, or tears.Section 8 ¿equipment storage and care¿ also contains information on ¿care of the driveline,¿ and provides possible indications of driveline damage.The heartmate ii lvas patient handbook, rev.C, is also currently available.Section 4 ¿living with the heartmate ii¿ contains information on caring for the driveline.Section 6 "caring for the equipment" discusses damage due to wear and fatigue of the driveline and outlines indications of driveline damage, as well as how to respond to such events.The relevant sections of the device history records for (b)(6) and the driveline were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit shipped on 21aug2009.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 13568936
• MDR Text Key: 286452695
• Report Number: 2916596-2022-00763
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011170
• UDI-Public: 813024011170
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2012
• Device Model Number: 103695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2009
• 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): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 87 KG