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

Model Number 106015

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems High Blood Pressure/ Hypertension (1908); Dizziness (2194); Hemolytic Anemia (2279); Thrombosis/Thrombus (4440)

Event Date 05/24/2022

Event Type  Injury  

Event Description

It was reported that the patient was seen in the clinic on (b)(6) 2022 where they started taking amlodipine for hypertension.Amlodipine was stopped (b)(6) 2022 because the patient's mean arterial pressure (map) was 60.The patient was admitted on (b)(6) 2022 for hemolytic anemia (ha) and short episodes of dizziness.They recently had elevated transaminases, and a computed tomography (ct) during arterial portography (ap) was performed in the emergency room (er).An incidental finding of intimal thrombus was noted in the outflow graft causing 60% stenosis distally.The patient had been experiencing more pulsatility index (pi) events than usual.A review of the log file revealed a cluster of pi events all throughout the log.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion.A direct correlation between (b)(6) and the reported thrombosis, hypertension, and patient conditions could not conclusively be determined through this evaluation.The reported thrombosis could not be confirmed through this evaluation as no images were submitted and no product was returned.The submitted log file captured transient pi events throughout the log file, resulting in momentary decreases in speed per design.No other atypical events were captured.The pump appeared to operate as intended.The patient remains ongoing on heartmate ii left ventricular assist system (lvas), serial number (b)(6).No product is available for investigation.The hmii ifu lists device thrombosis and hypertension as adverse events that may be associated with the use of the heartmate ii left ventricular assist system.The patient care and management section provides information on anticoagulation, including recommended inr values.This section also outlines indications of pump thrombosis, as well as how to respond to such events.The heartmate ii lvas ifu, rev.C, lists device thrombosis and hypertension as adverse events that may be associated with the use of the heartmate ii left ventricular assist system.The patient care and management section provides information on anticoagulation, including recommended inr values.This section also outlines indications of pump thrombosis, as well as how to respond to such events.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 29jun2015.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient was stable and did not receive any treatment for the outflow graft thrombus.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• 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 ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15017459
• MDR Text Key: 295950062
• Report Number: 2916596-2022-11944
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2015
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 116 KG