MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE III; LEFT VENTRICULAR ASSIST DEVICE

Device Problems Connection Problem (2900); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2021

Event Type  Injury  

Event Description

The patient arrived to clinic today with the white lead on controller damaged and a small tear on the silicone covering distal to the vad modular cable connector.The patient's driveline was found to be unlocked at the lvad modular cable connector.Reinforced previous education from 11/08/2019.Replaced the modular cable and controller.

• Brand Name: HEARTMATE III
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge dr.; pleasanton CA 94588
• MDR Report Key: 15105172
• MDR Text Key: 296650150
• Report Number: 15105172
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2022
• Distributor Facility Aware Date: 08/03/2021
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 07/21/2022
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 132 KG