MAUDE Adverse Event Report: ABBOTT LABORATORIES / THORATEC CORP. ABBOTT HEARTMATE 3 LVAD; VENTRICULAR (ASSIST) BYPASS

Model Number HEARTMATE 3

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Foreign Body In Patient (2687)

Event Date 07/13/2019

Event Type  Injury  

Event Description

Pt had hm3 implanted on (b)(6) 2018.On (b)(6) pt underwent orthotopic heart transplant (oth) and removal of hm3; the hm3 driveline looked grossly infected.On (b)(6), chest ct revealed a small portion of the dacron part of the driveline (2.8 cm) was retained in the right anterior musculature at the thoracoabdominal junction.It is not known if the piece was retained at the time of chest driveline removal (made more difficult due to the infection and embedded tissue) or at the time of exterior driveline removal upon completion of the oth procedure.

• Brand Name: ABBOTT HEARTMATE 3 LVAD
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): ABBOTT LABORATORIES / THORATEC CORP.
• MDR Report Key: 9027900
• MDR Text Key: 158637870
• Report Number: MW5089756
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HEARTMATE 3
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1