MAUDE Adverse Event Report: Thoratec Corporation THORATEC® HEARTMATE II®, LVAS IMPLANT KIT; Ventricular (Assist) Bypass

Model Number	107801
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Aortic Valve Insufficiency/ Regurgitation (4450); Skin Infection (4544)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a history of short-to-shield, which was still present after an external driveline repair was performed on (b)(6) 2026 (manufacturer report 2916596-2026-02141).The patient had come from another implanting facility and was a \"transfer and legacy encounter\".A heartmate 2 (hm2) to heartmate 2 pump only exchange was completed for short-to-shield on 09sep2026.The patient was in stable condition.A pre-operative transesophageal echocardiogram (tee) showed moderate to severe aortic insufficiency (ai).A post-operative echocardiogram showed severe ai which the site was addressing.It was also reported that the patient had chronic a chronic driveline exit site infection (dlesi) and was on doxycycline.The driveline exit site (dles) had moved to the left side with the new heartmate 2 pump implant.The patient was put on suppressive antibiotic therapy and managed by infectious disease physicians.The event had not resolved as the patient's condition was considered to be chronic.Images were not available.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

• Brand Name: THORATEC® HEARTMATE II®, LVAS IMPLANT KIT
• 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; +1(781)852-8207
• MDR Report Key: 50886641
• Report Number: 2916596-2026-2919803
• Device Sequence Number: 9826761
• Product Code: DSQ
• UDI-Device Identifier: 00813024011996
• UDI-Public: (01)00813024011996(17)190930
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Model Number: 107801
• Device Catalogue Number: 107801
• Device Lot Number: 5752231
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/21/2026
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2016
• 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: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 182 LB