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

Catalog Number 106015

Device Problems Migration or Expulsion of Device (1395); Infusion or Flow Problem (2964)

Patient Problem Dyspnea (1816)

Event Date 02/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Approximate age of device ¿ 2 years and 5 months.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.On (b)(6) 2018, technical services was contacted by the hospital to assess the patient¿s log files, and on (b)(6) 2018 the hospital confirmed that the patient experienced shortness of breath on exertion.An echocardiogram showed an increased gradient to the inflow cannula and low velocity at the outflow graft.The ct scan of the chest showed that the inflow cannula was in a sub-optimal position directed at the septum.Surgical intervention to re-position the inflow cannula was scheduled.No further information was provided at the time of this report.

Manufacturer Narrative

The device remains in use and was not available for evaluation.A correlation between the device and the reported flow issue could not be conclusively determined.The reported inflow malposition could not be confirmed through this evaluation.No imaging was submitted for evaluation.Log file analysis showed normal device operation above the low speed limit for the duration of the log file.The patient remains ongoing on heartmate ii lvas and no further events have been reported.A review of the device history records, including the sterilization and packaging documentation, found no deviations from manufacturing specifications.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
• 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: 7336296
• MDR Text Key: 102302557
• Report Number: 2916596-2018-00964
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 106015
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2015
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 87