MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE II®, LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSIST) BYPASS

Model Number	104911
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Purulent Discharge (1812); Pain (1994); Skin Infection (4544)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was reported that the patient had a left ventricular assist device (lvad) related para-device soft tissue infection since (b)(6) 2024.The patient had an lvad driveline wound pus discharge leading to re-hospitalization for infection survey and the patient was stable.The patient had symptoms of pus discharge at the driveline wound and the patient felt pain at the wound area.A computed tomography (ct) scan confirmed tissue infection around the lvad device pocket.The pus culture found proteus mirabilis and achromobacter spp.The patient was treated with oral moxifloxacin and then discharged.On (b)(6) 2025 the patient underwent a heart transplant.This was device or therapy related.The heart transplant resolved the infection and the driveline wound healed.The device operated as expected.The event date was estimated and the exact date was not provided.
Additional Manufacturer Narrative
Corrected data: section h6: health effect - clinical code corrected.Manufacturer's investigation conclusion: a correlation between the device and the report of infection could not be conclusively determined.Infection is listed in the instructions for use as a potential adverse event that may be associated with the use of heartmate ii left ventricular assist system.Infection has been previously investigated and will continue to be monitored through quality data reviews, which are conducted on production and post product signals to evaluate if products are conforming to product requirements.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE II®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 21755906
• Report Number: 2916596-2025-01926
• Device Sequence Number: 18597293
• Product Code: DSQ
• UDI-Device Identifier: 00813024011170
• UDI-Public: (01)00813024011170(17)170430
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2017
• Device Model Number: 104911
• Device Catalogue Number: 104911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 66 KG