MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS; LEFT VENTRICULAR ASSIST DEVICE

Catalog Number 107801

Device Problem Partial Blockage (1065)

Patient Problem Thrombus (2101)

Event Date 10/13/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Approximate age of device ¿ 6 months.The patient remains ongoing on lvad support.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017.It was reported on (b)(6) 2017 that the patient was seen in clinic for low flow alarms.An echocardiogram was completed and ¿looked great.¿ lvad speed was at 9000 rpm.Then overnight the lvad system had significant low flow alarms and lvad speed was increased.The patient¿s left ventricle (lv) was reportedly ¿big¿ and the right ventricle (rv) ¿small.¿ the inferior vena cava (ivc) was collapsible; 750ml fluid was given.Anticoagulation was 325mg aspirin and 100mg persantine.A speed echocardiogram (echo) on (b)(6) 2017 found that the left ventricle (lv) would not unload or aortic valve (av) close at pump speed of 10,800 rpms.The patient was bridged with heparin.Ct scan was found to be unremarkable.The patient was moved to the icu on (b)(6) 2017 for closer monitoring and placing of a central line.The thought process was reportedly right heart failure.Inotropes and nitric oxide were initiated.On (b)(6) 2017 a ct scan with contrast found partial thrombosis of the nonmetallic course of the outflow cannula, which resulted in approximately 60% luminal narrowing.Remaining segments of the inflow and outflow graft were not well evaluated due to significant beam hardening artifact.On (b)(6) 2017 the patient reportedly was doing well and lactate dehydrogenase (ldh) was stable.There were no power elevations or speed drops and no low flow alarms since the prior day.On (b)(6) 2017 it was reported that there were no power increases, the lactate dehydrogenase (ldh) was normal, and the patient was not exhibiting heart failure symptoms.It was reported on (b)(6) 2017 that the lvad speed increase had resolved the event; there were reportedly no further low flow alarms.The patient¿s status was reported as on nitric/epi and the patient was listed 1a for orthotopic heart transplant (oht) due to clot in the outflow graft.Starting on (b)(6) 2017 the low flow alarms (lfas) returned.Pump speed was increased to 9800 rpm and the alarms decreased in frequency.No further speed echos or ct scans were performed.The patient remained on 0.04 epi/5 dobutamine.End organ function was reportedly doing well.Svo was 60%.The patient had been reportedly stable over the previous couple of weeks.On (b)(6) 2017 it was reported that the patient continued to have low flow alarms.The patient was on epi at 0.04 and dobutamine at 5.The patient reportedly ¿feels great,¿ and labs looked good.The patient was just very tired from not sleeping.The patient was on intra-aortic balloon pump (iabp), which began on an unspecified date.

Manufacturer Narrative

Corrected information - approximate age of device ¿ 6 months, 13 days (calculated based on the date that lvad support was discontinued on (b)(6) 2017).The event reported under this report was also reported by the manufacturer under medwatch mfr # 2916596-2018-00722.No further information is available.The manufacturer has closed the file on this event.

Event Description

Additional information and correction to the initial reported event: upon further clarification from the vad coordinator, after the initial reported event that occurred on (b)(6) 2017, the patient¿s pump was turned off on (b)(6) 2017 but remained in-situ.Due to high risk of mortality, the healthcare professionals deemed the patient not a candidate for a pump exchange.On (b)(6) 2018, the patient was transferred to another lvad implanting center for further evaluation where, during a re-do sternotomy procedure on (b)(6) 2018, the device (which had remained in-situ and off for approximately 11.5 weeks) was explanted.The patient subsequently expired on (b)(6) 2018.

Manufacturer Narrative

Explant date was not provided.Corrected information.It was initially reported that the device would not be returned.The pump was subsequently exchanged.The removed device was received for investigation.The evaluation is not yet complete.

Event Description

It was reported that the patient was transferred to another implanting center, (b)(6) on (b)(6) 2018 for pump exchange.The exchange was due to pump thrombus.

Manufacturer Narrative

Device evaluation: thrombus was confirmed through the evaluation of the returned device, (b)(4).The pump was returned assembled with the driveline cut approximately 2.5 inches from the pump housing and the severed distal end portion, measuring approximately 36 inches in length, was returned.The sealed inflow conduit was returned attached to the pump¿s inlet port and the sealed outflow graft was returned attached to the pump's outlet port with approximately 1 inch of graft material.The sealed outflow graft bend relief and bend relief collar were returned unattached.Examination of the blood-contacting surfaces found depositions in the sealed inflow conduit, sealed outflow graft, and in the pump.The depositions had formed biological lining that extended from the inlet tube through all three of the inlet stator, rotor, and outlet stator vanes, to the outflow graft as one continuous piece.The depositions appeared consistent with poor surface washing resulting from an interruption in flow.Although a root cause for the flow interruption could not be conclusively determined through this evaluation, it could have contributed to the patient's low flow events observed in the submitted log files.Upon removal of the observed depositions, the device was cleaned.The disassembled pump¿s bearings, rotor, and blood-contacting surfaces were examined under a microscope and no anomalies were observed.Electrical continuity testing of the driveline did not reveal any discontinuities or shorts.The pump was reassembled and functionally tested under normal operating conditions using a mock circulatory loop.The data retrieved from that testing revealed normal pump power consumption and pressure values, comparable to what was recorded during the manufacturing process and the device functioned as intended.The hmii lvas ifu lists device thrombosis as an adverse event that may be associated with the use of the heartmate ii left ventricular assist system and provides information regarding the recommended anticoagulation therapy and inr range.A review of the device history records revealed that the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient was not considered a surgical candidate for pump exchange at the implanting center, (b)(6), due to high risk of mortality.The patient was then transferred to transferred to (b)(6) hospital for evaluation.

• Brand Name: HEARTMATE II LVAS
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• 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 ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7015460
• MDR Text Key: 91543323
• Report Number: 2916596-2017-02689
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 107801
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 94