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

Catalog Number 106015

Device Problem Partial Blockage (1065)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 09/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Approximate age of device ¿ 1 year and 11 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) 2015.It was reported that on (b)(6) 2017 during routine clinic visit abnormal vad parameters of suboptimal pump flow were observed upon interrogation.It was reported that the patient had a recent history of sub-therapeutic inrs requiring lmw heparin bridging.On (b)(6) 2017 the patient was taken to the cath lab for placement of 4 stents to the outflow graft, beginning a couple of centimeters above the outflow graft and pump connection.It was reported that there were no complications.Prior to stent placement, the patient¿s lactate dehydrogenase (ldh) was 262u/l and inr was 2.7.The patient was discharged home on (b)(6) 2017.

Manufacturer Narrative

Corrected information: the patient was initially discharged home on lvad support.Subsequently, the patient was transplanted and the device is being returned.

Event Description

Additional information: it was reported that the patient received a heart transplant on (b)(6) 2017.The patient had been listed as status 1a secondary to outflow graft pump thrombosis, but the transplant was reportedly routine.The pump was released from pathology and on (b)(6) 2017 was to be retuned for evaluation.

Manufacturer Narrative

No device-related issues were discovered and the report of pump thrombosis could not be confirmed through the evaluation of the left ventricular assist system (lvas).A direct correlation between the evaluation findings of the returned device and the reported suboptimal pump flows could not be conclusively determined.The submitted system controller log file contained data from (b)(6) 2017 - (b)(6) 2017 and showed that pump power, estimated flow, and average pi appeared to be trending downward over time starting on (b)(6) 2017; however, no atypical alarms were captured and the pump speed remained above the low speed limit for the duration of the log file.It was reported that the patient had thrombosis in the outflow graft and stents were placed in the graft with a subsequent increase in pump flow readings.The lvas was returned assembled with the driveline severed approximately 3 inches from the nipple of the pump housing and an additional adjacent driveline segment measuring approximately 15 inches in length was also returned.The distal end of the driveline was not returned.The sealed inflow conduit (inlet tube, flex section, and inlet elbow) was returned detached from the pump's inlet port.The outlet elbow was returned attached to the pump's outlet port.The sealed outflow graft was returned with the graft material severed approximately 1.5 inches from the attachment hardware and the graft attachment was returned detached from the outlet elbow.The severed portion of the outflow graft was not returned.The sealed outflow bend relief collar was returned; however, the outflow graft bend relief was not returned.Visual inspection of the sealed inflow conduit revealed no evidence of depositions or thrombus formations that would have contributed to a functional issue.In addition, visual examination of the returned portion of the sealed outflow conduit as well as the pump¿s blood-contacting surfaces upon disassembly of the lvas revealed no evidence of depositions or thrombus formations.The returned portions of the driveline appeared unremarkable and electrical continuity testing of the driveline segments did not reveal any discontinuities or shorts.Functional testing of the pump under normal operating conditions revealed normal pump power consumption and pressure values and the pump operated as intended.Thrombus is listed in the instructions for use as a potential adverse event that may be associated with the use of the heartmate ii left ventricular assist system.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.

• Brand Name: HEARTMATE II LVAS
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 6984433
• MDR Text Key: 90462714
• Report Number: 2916596-2017-02492
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 106015
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 95