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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abscess (1690); Post Operative Wound Infection (2446)

Event Date 12/27/2016

Event Type  Injury  

Event Description

Patient with left ventricular assist device (lvad) therapy for 23 months presents with second episode of driveline infection requiring hospitalization and iv antibiotics.A positive abscess formation required surgical incision and drainage and vacuum assisted closure (vac) dressing.No sepsis.Patient is discharged with higher burden of care (vad, vac, peripherally inserted central catheter (picc), iv antibiotics).

• Brand Name: HEARTMATE II LVAS
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 4550 norris canyon rd.; san ramon CA 94583
• MDR Report Key: 6379943
• MDR Text Key: 69115680
• Report Number: 6379943
• 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: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• 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: 02/13/2017
• Device Age: 23 MO
• Event Location: Home
• Date Report to Manufacturer: 02/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS.; NO
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 108