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U.S. Department of Health and Human Services

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

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THORATEC CORPORATION HEARTMATE 2 VENTRICULAR (ASSIST) BYPASS Back to Search Results
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.
 
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Brand NameHEARTMATE 2
Type of DeviceVENTRICULAR (ASSIST) BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
MDR Report Key12512241
MDR Text Key272690905
Report Number12512241
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received09/22/2021
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 FDA09/09/2021
Device Age3 YR
Event Location Home
Date Report to Manufacturer09/22/2021
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

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