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

Model Number 104911

Device Problems Restricted Flow rate (1248); Infusion or Flow Problem (2964)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2019

Event Type  Injury  

Manufacturer Narrative

No patient information provided.Approximate age of device ¿ unknown; patient information was requested but not provided.The patient remains ongoing with the lvad device.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 left a ventricular assistance device (lvad).It was reported that the patient was having persistent low flow alarms which is from mixed etiology.Patient was previously diagnosed with diabetes insipidus and losing large volumes through urine but now has a extrinsic stenosis on the outflow graft.Additional information was requested but not provided.

Manufacturer Narrative

The serial number of the device was requested multiple times but not provided.Therefore, udi, manufacturing date, implant date, & expiration date are unknown.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported stenosis of the outflow graft could not be confirmed through this evaluation.Additionally, the report of low flows was confirmed through the evaluation of the submitted log files.The alarms occurred due to the estimated flow being calculated below the low flow threshold of 2.5 lpm.There was one low speed advisory alarm due to the pump speed being manually set below the low speed limit.The alarm resolved when the pump was set back to above the low speed limit.The system appeared to be operating as intended.The heartmate ii left ventricular assist system instruction for use (ifu) explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.This document also explains that physiological factors that affect the filling of the pump, such as hypovolemia or postural hypotension, result in reduced pump flows as long as the condition persists.Pump flows are not restored to normal unless such conditions are treated.The ifu outlines all system controller alarms (including low flow hazard and low speed advisory alarms), as well as how to respond to such events.The ifu also outlines considerations for pump placement and provides instructions regarding the preparation, installation, and orientation of the sealed outflow graft.The ifu specifically states: "the sealed outflow graft must not be kinked or positioned where it could abrade against a pump component or body structure" and "verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief.The line should be straight.".

Manufacturer Narrative

No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 8442419
• MDR Text Key: 139530748
• Report Number: 0002916596-2019-01252
• Device Sequence Number: 1
• Product Code: DSQ
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 104911
• Device Catalogue Number: 104911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 06/19/2019; 06/26/2019; 03/08/2024
• Supplement Dates FDA Received: 06/25/2019; 06/26/2019; 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Removal/Correction Number: FA-Q124-HF-1
• Patient Sequence Number: 1
• Patient Outcome(s): Other