MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524US

Device Problems Obstruction of Flow (2423); Protective Measures Problem (3015)

Patient Problems Hemorrhage/Bleeding (1888); Dizziness (2194)

Event Date 09/08/2021

Event Type  malfunction  

Event Description

Senior male patient with a history of end-stage non-ischemic cardiomyopathy status post heartmate 3 lvad implant about three years ago, along with asd (atrial septal defect) closure, right femoral artery and iliac thrombectomy with patch repair, and removal of thrombus on ra lead.He was recently admitted for recurrent low-flow alarms on his lvad, found to have outflow graft obstruction and severe ai, s/p surgical revision of his outflow graft followed by tavr (transcatheter aortic valve replacement) in (b)(6) 2021 with excellent clinical result who presented on (b)(6) with black stools, lightheadedness and significant hgb drop consistent with gi bleed.The patient recently presented to the ed with spots of bright red blood after straining to have a bowel movement, found to have a stable hgb, and discharged home.Bleeding was felt not to be related to vad.He then reported about a week of black stools.An inr (international normalized ratio) performed at admission revealed the patient was supertherapeutic on warfarin.He had a colonoscopy which showed blood from the terminal ileum.A cta (computed tomography angiography) abdomen/pelvis obtained which showed a blush of contrast in the appendix seen on arterial phase with pooling of contrast seen on delayed phase imaging in the cecum and appendix consistent with active contrast extravasation.This is likely arising from ileocolic branch of superior mesenteric artery.The patient received two units of blood for a hct of 20.

• Brand Name: THORATEC HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 12487448
• MDR Text Key: 271890030
• Report Number: 12487448
• 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: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 106524US
• Device Catalogue 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: 09/13/2021
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 09/17/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21170 DA
• Patient Weight: 70