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

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 05/25/2020

Event Type  Injury  

Event Description

Patient with implanted heartmate iii left ventricular assist device (lvad) was admitted due to a right frontal cerebrovascular accident (cva) in the setting of inr 1.4, aspirin 81 mg daily.Labs/imaging on admission include: ldh 220, haptoglobin 112, plasma hemoglobin 22, normal lvad function, normal carotid study, and normal transcranial doppler study.A 4d chest ct was performed to assess orientation of the lvad due to past history of inflow cannula malposition requiring surgical reposition/reorientation 3 months ago; compared to the prior study the angle of the device appears less steep, tilting the opening away from the myocardium.Patient neuro symptoms have returned to his baseline despite repeat brain ct continuing to show hypodensity in the right frontal region.

• Brand Name: HEARTMATE III
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 12518497
• MDR Text Key: 272970623
• Report Number: 12518497
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/09/2021

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
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2021
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 09/23/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 20440 DA
• Patient Weight: 75