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

Catalog Number 106015

Device Problems Pumping Stopped (1503); Cut In Material (2454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Approximate age of device ¿ 1 year, 5 months.The lvad currently remains implanted in the patient but is not in use.The report of the patient cutting through the driveline was confirmed via a submitted photo which showed a completely severed driveline.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.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 on (b)(6) 2017, the patient cut through the driveline and the pump stopped.The patient was stable and asymptomatic.The patient was admitted to the implanting center, where a decision was made to leave the pump in place given the patient¿s stable hemodynamics.The driveline was cut at the skin level on (b)(6) 2017 and the patient was discharged the following day on (b)(6) 2017.No additional information was provided.

Manufacturer Narrative

The inlet tube with a small section of the inflow conduit flex section was returned for investigation.Device evaluation: the report that the patient cut through the driveline was confirmed via a submitted photograph.The patient was reportedly stable and asymptomatic.Examination of the inlet tube and the returned section of the inlet conduit flex section revealed no adhered depositions or thrombus formations.No anomalies were noted.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the pump was exchanged to another manufacturer¿s device on (b)(6) 2017.No additional information was provided.

• 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: 6839114
• MDR Text Key: 84620320
• Report Number: 2916596-2017-01949
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 106015
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2015
• 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 Age: 41 YR
• Patient Weight: 109