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

Model Number 106015

Device Problems Restricted Flow rate (1248); Malposition of Device (2616)

Patient Problems Fatigue (1849); Dizziness (2194); Blood Loss (2597)

Event Date 06/20/2019

Event Type  Injury  

Manufacturer Narrative

Approximate age of device ¿ 4 years, 11 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 (lvad) on (b)(6) 2014.It was reported that the patient's inflow cannula was pointed right at the septum and the patient had worsened pump function.The patient was taken to the operating room (or) for a heartmate ii pump exchange.Before the exchange the patient had been experiencing fatigue, nausea, shortness of breath, dizziness and low flow alarms.On (b)(6) 2019 the patient was still in the intensive care unit (icu), was not stable hemodynamically and was still intubated.There was bleeding post exchange and the patient was returned to the or for washout.Vad flows had improved and the patient's mean arterial pressures (maps) were normal.The plan was to continue with inotrope/vasopressor support and extubate when stable.

Manufacturer Narrative

Additional information.Manufacturer's investigation conclusion: the evaluation of (b)(6) did not reveal any device-related issues.The report that the inflow cannula was pointed right at the interventricular septum could not be confirmed through the evaluation of the returned device; no x-ray images or ct scans were provided.The cause of the report of low flow alarms could not conclusively be determined as no log file was provided.Furthermore, a direct correlation between the returned device and the reported events could not be conclusively determined.The pump was returned assembled with the driveline (dl) cut approximately 9¿ from the pump housing and the distal portion was returned measuring approximately 29¿.The inflow conduit (inlet tube, flex section, and inlet elbow), outflow graft, outflow graft bend relief, and bend relief collar were not returned.The 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)(6) also revealed no evidence of adhered 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.

• 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
• MDR Report Key: 8768641
• MDR Text Key: 150299509
• Report Number: 2916596-2019-03146
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 83