MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSIST) BYPASS

Model Number 1355

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

Patient Problems Purulent Discharge (1812); Skin Infection (4544)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had a known driveline fault and chronic driveline infection.It was later communicated that the driveline infection began in 24sep2020 and was treated with chronic antibiotics.The driveline fault was caused by exposed wires due to significant compromise of the silicone outer covering with purulent drainage coming out of the driveline.

Manufacturer Narrative

Manufacturer's investigation conclusion: driveline faults reportedly associated with exposed wires due to significant compromise of the outer jacket of the driveline cannot be confirmed through this evaluation as no log files or images were submitted for review.Additionally, a specific cause for the reported driveline infection cannot be conclusively determined through this evaluation.The patient remained ongoing on heartmate ii left ventricular assist system (lvas) until they underwent a heartmate ii to heartmate 3 pump exchange on (b)(6) 2024.The relevant sections of the device history records and driveline were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 of this ifu lists infection as an adverse event that may be associated with the use of the heartmate ii left ventricular assist system.Care instructions in regard to preventing infection are provided in various sections of this ifu, including a section entitled "controlling infection." section 6 ¿patient care and management¿ discusses damage due to wear and fatigue of the driveline.This section also contains information on ¿caring for the driveline¿ (under ¿ongoing system assessment and care¿) and provides possible indications of driveline damage as well as how to respond to such events.Section 7 "alarms and troubleshooting" outlines system controller alarms as well as how to respond to each alarm condition.Section 8 ¿equipment storage and care¿ also contains information on ¿care of the driveline,¿ and provides possible indications of driveline damage.The heartmate ii lvas patient handbook is also currently available.Section 4 ¿living with the heartmate ii¿ contains information on caring for the driveline.Section 5 "alarms and troubleshooting" outlines system controller alarms as well as how to respond to each alarm condition.This handbook also contains a section on ¿caring for the driveline¿ ¿ however, all heartmate ii left ventricular assist device (lvad) percutaneous leads have the potential for wire/shield breakdown to occur dependent upon length of use movement/flexing over time.This section also outlines proper driveline maintenance.If driveline damage is suspected, the user is instructed to call their hospital contact immediately.The patient handbook also contains information about preventing infection.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
• 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: 18750816
• MDR Text Key: 335896482
• Report Number: 2916596-2024-00807
• Device Sequence Number: 1
• Product Code: DSQ
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2014
• Device Model Number: 1355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2007
• 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): Life Threatening; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 107 KG