MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC HEARTMATE 3 LVAD; VENTRICULAR (ASSISST) BYPASS

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Bacterial Infection (1735); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/23/2021

Event Type  Injury  

Event Description

Patient implanted with a heartmate 3 left ventricular assist device (lavd) with chronic cipro-resistant pseudomonas driveline infection was admitted for third hospitalization with worsening infection symptoms only four weeks after previous course of iv antibiotics (meropenem) ended.Cultures confirmed meropenem resistance, with addition of new pseudomonas bacteremia.The infection course was additionally complicated by culture-confirmed infection of left knee hardware.From a surgical standpoint, patient required a total of three surgical incisions and drainages (i&d) to the driveline tract on this year alone.A wound vacuum-assisted closure (vac) dressing was also applied.Patient also required a surgical i&d of the left knee with poly exchange after three separate attempts to reduce the knee dislocations that occurred during this year.Patient was discharged on avycaz course.

• Brand Name: THORATEC HEARTMATE 3 LVAD
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 12506170
• MDR Text Key: 272464026
• Report Number: 12506170
• 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: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• 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: 09/09/2021
• Device Age: 29 MO
• Event Location: Home
• Date Report to Manufacturer: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 25550 DA
• Patient Weight: 98