MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 2 VENTRICULAR (ASSIST) BYPASS

Device Problem Fracture (1260)

Patient Problems Anemia (1706); Gastrointestinal Hemorrhage (4476); Melena (4480)

Event Date 05/23/2020

Event Type  malfunction  

Event Description

Patient with implanted heartmate 2 left ventricular assist device (lvad), with known driveline fracture, is admitted to the hospital due to the first event gastrointestinal bleeding (melena with anemia) in the setting of inr 1. 9 and aspirin 81 mg daily. Inr allowed to drift. Five units of transfused blood were required. Endoscopic evaluation included egd (normal), colonoscopy (blood observed throughout the entire colon), and angiography (bleeding source not identified). Decision regarding the continuation of coumadin/aspirin ongoing given this palliative patients burden of comorbidities.

• Brand Name: HEARTMATE 2
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 12512241
• Report Number: 12512241
• 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

• 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: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2021
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 09/22/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Patient Age: 25915 DA
• Patient Weight: 65