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

Model Number 106015

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Arrhythmia (1721)

Event Date 03/10/2016

Event Type  Injury  

Manufacturer Narrative

Approximate age of device ¿ 0 days.Manufacturer's investigation conclusion: no product was returned for evaluation.The report of a malpositioned inflow conduit and a specific cause for the reported cardiac arrhythmia could not be conclusively determined.The patient remains ongoing on lvad support.The instructions for use lists cardiac arrhythmia as an adverse event that may be associated with the use of the hm ii lvas.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 (lvad) on (b)(6) 2016.It was reported that the patient was hemodynamically stable after implant on (b)(6) 2016; however, developed frequent ventricular arrhythmias on night of post op day 0.This was investigated with transesophageal echocardiography (tee), revealing a small left ventricle, with the left ventricular inlet cannula directed towards the intraventricular septum and in contact with it.This was initially managed medically with volume and decreasing the lvad pump speed with good results, however, as this potentially represented a long-term problem for the patient, the surgeon decided to return to the operating room on (b)(6) 2016 to adjust the cannula position.No additional information was provided.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 8053198
• MDR Text Key: 126638615
• Report Number: 2916596-2018-04838
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• 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,study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/22/2018
• Initial Date FDA Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2016
• 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: 48 YR
• Patient Weight: 106