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); Decreased Pump Speed (1500); Pumping Stopped (1503); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Renal Failure (2041)

Event Date 04/01/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had low flow and low speed alarms on the evening of 01apr2024 when they tried to switch from battery to wall power.The care provider thought that the patient had driveline damage, but supposed it was possible that the patient had a power module issue even though the power module was not alarming.The patient's device was interrogated.This interrogation revealed pump speed dropping to 0 with associated expected alarms.The patient made plans to come in on 05apr2024.Of note, the alarms began occurring after the patient had a controller exchange due to wire damage on the power lead connecting from the patient's former primary system controller to their battery clips.The alarms re-occurred on 02apr2024 and 03apr2024.On 05apr2024, the patient had another controller exchange due to wear and tear on the controller.A chest x-ray was performed.During the pump off episodes, lasting in some cases 20 seconds, the patient did not lose consciousness or feel any more unwell than normal.Technical services were onsite 08apr2024 and a driveline repair was performed.No alarms occurred while the abbott team was present.X-ray images were viewed onsite and the technical service team did not see any obvious areas of concern.The entire external portion of the driveline was replaced with no issues.The patient was placed on a grounded patient cable post-repair.The alarm did not return.Of note, the patient had a chronic infection history and was on chronic antibiotics, was dialysis dependent (3 days per week), had numerous digit/limb amputations, and had several other comorbid conditions.Related mfr #2916596-2017-00108 captured pump exchange on 23aug2016 due to driveline infection.

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 19165320
• MDR Text Key: 340856062
• Report Number: 2916596-2024-02158
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: (01)00813024011224(10)5761031(17)190930
• 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: Physician Assistant
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Model Number: 106015
• Device Lot Number: 5761031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/22/2016
• 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): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 119 KG