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

Catalog Number 106015

Device Problems Output above Specifications (1432); Device Stops Intermittently (1599); Cut In Material (2454)

Patient Problem No Code Available (3191)

Event Date 10/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Approximate age of device ¿ 60 days.A full evaluation of the device could not be conducted as the device remains in use.The reported motor stop event and power elevations were confirmed per evaluation of the submitted log file.However, the reported damage to the internal portion of the driveline could not be confirmed.The instructions for use explains that pump power is a direct measurement of motor voltage and current; therefore, changes in pump speed, flow, or physiological demand can affect pump power.This document also notes that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.The patient remains on vad support.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient was implanted with a left ventricular assist device.It was reported that on (b)(6) 2015 the patient underwent a procedure to have a jejunostomy tube placed.During the procedure the physician reportedly "nicked the internal driveline with a needle, which caused a brief pump stop to occur." the damage to the driveline was reportedly internal at the lower left quadrant.No further intervention was taken at that time and no further pump stoppages were reported.On (b)(6) 2015, the patient experienced sustained power elevations after undergoing aggressive diuresis with a bumex gtt.The diuretics were held on (b)(6) 2015 and the patient's parameters were back to baseline on (b)(6) 2015.On (b)(6) 2015 the patient experienced sustained power elevations again.On (b)(6) 2015 the patient's parameters came back to baseline where they have been sustained to date.The patient's anticoagulation has been therapeutic throughout the course of events.It was reported that there were no signs/symptoms of hemolysis or heart failure.On (b)(6) 2015, the patient's lactate dehydrogenase was measured and was within normal limits.The patient also had an echocardiogram, which revealed moderate aortic regurgitation and mitral regurgitation.The manufacturer's technical services reported that the driveline fault detection circuitry indicated that there were currently no issues with the driveline in its current state.

Manufacturer Narrative

The report of pump stoppage event and pump power elevations was confirmed based on the evaluation of the submitted log file.Evaluation of the returned pump confirmed cuts to the internal portion of the driveline that were consistent with a cutting tool, and not with a needle.The report of red heart alarms could have occurred as a result of the exposed conductors of one wire contacting the braided shielding when the device was supported by the power module; however, the time frame for when the damage occurred could not be conclusively determined.Furthermore, evaluation of the device confirmed thrombus inside the pump, which may have caused the observed pump power elevations.The driveline was cut less than 1 inch from the pump housing and a continuing, approximately 13 inch portion of the severed driveline was returned.Damage to the outer jacket, bionate layer, metal shielding, and wires were found throughout the driveline.The underlying wire conductors were exposed.The damage appeared to have been caused by surgical tools.Damage consistent with a needle puncturing the driveline was not identified.Examination of the rotor, blood tube, and outlet stator revealed white/dark red, fixed depositions.Due to the fixative, the evaluation could not conclusively determine the origin of these depositions nor the duration of their presence in the pump.However, the presence of contact marks on the rotor suggest that a deposition was likely present inside the pump while the device was supporting the patient.The instructions for use lists thrombus 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 showed no deviations from manufacturing or qa specifications.No further information was provided.The manufacturer is closing its file on this event.

Event Description

Additional information: it was reported by the clinical representative stated that the patient expired on (b)(6) 2016 due to metabolic acidosis, septic/cardiogenic shock.According to the surgical director, the patient outcome was not device or therapy related.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 651756-407
• MDR Report Key: 5275583
• MDR Text Key: 33378122
• Report Number: 2916596-2015-02322
• 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
• Report Date: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 106015
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2015
• 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 Age: 50 YR
• Patient Weight: 88