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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Discharge (2225)

Event Date 02/20/2019

Event Type  Injury  

Event Description

Heartmate 2 presents with acute exacerbation of chronic pseudomonas driveline infection requiring extensive surgical incision and drainage (i & d) of the driveline tract with relocation of the driveline, with reoperation for bleeding the next day.Vacuum assisted closure (vac) dressing was required for wound closure.Iv antibiotics required for discharge home.

• Brand Name: HEARTMATE II LVAS
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge dr; pleasanton CA 94588
• MDR Report Key: 9005750
• MDR Text Key: 157761353
• Report Number: 9005750
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/23/2019

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: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2019
• Device Age: 4 YR
• Event Location: Home
• Date Report to Manufacturer: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 18615 DA
• Patient Weight: 79