MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP; VENTRICULAR (ASSIST) BYPASS

Model Number 105306

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Gastrointestinal Hemorrhage (4476)

Event Date 12/15/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation conclusion: 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.

Event Description

It was reported that on (b)(6) 2021 the patient was readmitted for major bleeding in the lower gastrointestinal tract and was discharged on (b)(6) 2021.Less than four units of red cell concentrate per 24 hours were transfused.The patient was on warfarin at the time of the event.The patient had a documented history of lesions at the site of bleeding that could have potentiated the bleeding episode.The source of the bleed had been determined to be the small intestine.Blood transfusion was performed for fast fluid replacement management, which was considered a symptomatic treatment.The patient's bleed was resolved with a conservative therapy.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP
• Type of Device: 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15107368
• MDR Text Key: 296652676
• Report Number: 2916596-2022-12172
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Model Number: 105306
• Device Lot Number: IFS103828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male