MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSISST) BYPASS

Model Number 106015

Device Problems Device Alarm System (1012); Appropriate Term/Code Not Available (3191)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888)

Event Date 12/27/2019

Event Type  Injury  

Manufacturer Narrative

This event was initially reported under mfr # 2916596-2017-02059 and mfr # 2916596-2017-02057 manufacturer's investigation conclusion: the evaluation of heartmate ii lvas, serial number (b)(4), did not reveal any device-related issues.The patient was found to have a match for a donor heart and underwent a heart transplant on (b)(6) 2017.The pump was returned assembled with the driveline (dl) cut approximately 6¿ from the pump housing and the remaining distal portion of the dl was not returned.The inflow conduit (inlet tube, flex section, and inlet elbow), outflow graft, outflow graft bend relief, and bend relief collar were not returned.Outflow elbow was returned attached to the pump¿s outlet port.Evaluation of the outflow elbow revealed no evidence of depositions or thrombus formations.Visual examination of the pump¿s blood-contacting surfaces upon disassembly of (b)(4) also revealed no evidence of depositions or developed thrombus formations.The disassembled pump¿s bearings, rotor, and blood-contacting surfaces were examined under a microscope and no anomalies were observed.Electrical continuity testing of the driveline did not reveal any discontinuities or shorts.The pump was cleaned, reassembled and functionally tested under normal operating conditions using a mock circulatory loop.The data retrieved from that testing revealed normal pump power consumption and pressure values, comparable to what was recorded during the manufacturing process and the device functioned as intended.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient had episodes of stroke and gastrointestinal bleeding.The patient was reported to be doing fairly well over the last 2 years.The patient was found to have a match for a donor heart and underwent a heart transplant on (b)(6) 2017.There were no alarms or abnormal pump parameters seen and the patient was asymptomatic.The explanted pump was received on (b)(6) 2019.No additional information was provided.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• 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: 9805656
• MDR Text Key: 184063850
• Report Number: 2916596-2020-01101
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2015
• 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: 67 YR
• Patient Weight: 73