MAUDE Adverse Event Report: ABBOTT LABORATORIES HEARTMATE 3 LVAD; VENTRICULAR (ASSIST) BYPASS

Model Number 106524US

Patient Problems Intracranial Hemorrhage (1891); Muscle Weakness (1967); Numbness (2415)

Event Date 02/12/2024

Event Type  Injury  

Event Description

The patient is a senior man on warfarin for anticoagulation.He presented to an outside hospital with left sided weakness and numbness.A head ct revealed a large right intraparenchymal hemorrhage with intraventricular extension.His inr upon presentation at the outside hospital was 2.2.He was transferred to [redacted name] for further care.After neurology evaluation and discussion with family, he was made comfort measures only.

• Brand Name: HEARTMATE 3 LVAD
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): ABBOTT LABORATORIES; 6101 stoneridge dr.; pleasanton CA 94588
• MDR Report Key: 18776754
• MDR Text Key: 336205245
• Report Number: 18776754
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 106524US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2024
• Device Age: 7 MO
• Event Location: Home
• Date Report to Manufacturer: 02/26/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Race: White