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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE III; LEFT VENTRICULAR ASSIST DEVICE
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THORATEC CORPORATION HEARTMATE III; LEFT VENTRICULAR ASSIST DEVICE Back to Search Results
Device Problem Material Deformation (2976)
Patient Problems Muscle Weakness (1967); Cognitive Changes (2551)
Event Date 05/27/2021
Event Type  Injury  
Event Description
Patient implanted with heartmate 3 on (b)(6) 2021.Pt with symptoms of altered mental status and left sided weakness due to hypo-perfusion on "(b)(6)." "(b)(6)" ct with noted kinking at the outflow graft."(b)(6)" surgery with noted outflow graft being pushed medially by the lungs, giving it a very acute angle as it traverses over the lower right atrium and down toward the ivc, then sharply up toward the right shoulder before straightening out and anastomosing to the aorta.A 6-cm segment of the outflow graft was cut between the two grafts and removed with the two remaining ends grafted together.
 
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Brand Name
HEARTMATE III
Type of Device
LEFT VENTRICULAR ASSIST DEVICE
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge dr
pleasanton CA 94588
MDR Report Key13950298
MDR Text Key290523922
Report Number13950298
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/21/2022
Distributor Facility Aware Date05/27/2021
Device Age1 MO
Event Location Hospital
Date Report to Manufacturer03/21/2022
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age63 YR
Patient SexMale
Patient Weight141 KG
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