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

Model Number	103695
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperemia (1904); Epistaxis (4458); Gastrointestinal Hemorrhage (4476)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information provided.A supplemental report will be submitted once the manufacturer investigation is complete.
Event or Problem Description
It was reported that the patient was admitted for gastrointestinal (gi) bleeding on (b)(6) 2023.An esophagogastroduodenoscopy (egd) was performed without evidence of active bleeding and no clear source of melena.The patient was on warfarin for the left ventricular assist device (lvad).They had blood in their esophagus consistent with epistaxis, and a friable hyperemic duodenum.Two polyp biopsies were taken.It was decided to discontinue all anticoagulation given the risk of gi bleed reoccurrence.The patients result for helicobacter pylori (h.Pylori) was negative.They received 3 units packed red blood cell (prbc).They were started on an intravenous (iv) proton pump inhibitor (ppi) with conversion to oral pantoprazole 40mg bi-daily for 8 weeks.The patient was discharged on (b)(6) 2023.
Additional Manufacturer Narrative
D4: expiration date and primary udi number, updated h4: device manufacture date, updated the pump remains in use supporting the patient.A correlation between the device and the report of gastrointestinal (gi) bleeding could not be conclusively determined.Bleeding 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.Gi bleeding 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, US, EP
• 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: 21234727
• Report Number: 2916596-2025-00458
• Device Sequence Number: 8206332
• Product Code: DSQ
• UDI-Device Identifier: 00813024010616
• UDI-Public: (01)00813024010616(17)140830
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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: 08/30/2014
• Device Model Number: 103695
• Device Catalogue Number: 103695
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2010
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 80 KG