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

Model Number 106524INT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thromboembolism (2654); Gastrointestinal Hemorrhage (4476)

Event Date 07/12/2021

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that at a routine outpatient visit, hemoglobin was at 8.0 g/dl on (b)(6) 2021.Patient reports blood in stool.It was planned to admit patient to clinic for transfusion on (b)(6) 2021.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the device and the reported gastrointestinal bleeding and ulcer of ischemic origin could not be conclusively determined through this evaluation.The account communicated that the patient experienced gastrointestinal bleeding (gib) and melena.The patient received blood transfusion during a day clinic admission on (b)(6) 2021.An esophagogastroduodenoscopy (egd) and colonoscopy were performed on (b)(6) 2021 showing an ulcer of most probably ischemic origin at the right colon flexure.A third colonoscopy on (b)(6) 2021 showed that the ulcer had reduced in size, but not resolved.The patient¿s symptoms resolved on (b)(6) 2021, and they haven¿t reported any further symptoms.On (b)(6) 2021, the ulcer had not resolved, and the patient¿s medication was updated accordingly.A reevaluation colonoscopy was planned in 6 weeks.The patient remained ongoing on heartmate 3 lvas, (b)(6).No product is available for investigation.The relevant sections of the device history records for (b)(6) was reviewed and showed no deviations from manufacturing or quality assurance specifications.The product shipped on (b)(6) 2021.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) lists bleeding, venous thromboembolism, and arterial non-central nervous system (cns) thromboembolism as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.This document provides information regarding anticoagulation, including recommended international normalized ratio (inr) values, and the suggested anticoagulation modifications in the event that there is a risk of bleeding.Section 5 "surgical procedures" (under ¿preparing the ventricular apex site¿) instructs to inspect the ventricular chamber for mural thrombi and crossing trabeculae following removal of the core and to address one or both, as needed.This section also states that pump function will be compromised in the presence of inlet obstruction.Section 5 (under ¿implant procedures¿) additionally warns to inspect the ventricle and remove any previously formed clots that may cause embolism or any trabeculae that may impede flow.Section 6 "patient care and management" (under "anticoagulation") contains information regarding the recommended anticoagulation therapy for patients using the device.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that at a routine outpatient visit, hemoglobin was at 8.0 on (b)(6) 2021.Patient reports blood in stool.It was planned to admit patient to clinic for transfusion on (b)(6) 2021.An egd and colonoscopy were performed on (b)(6) 2021 showing an ulcer of most probably ischemic origin at the right colon flexure.It was reported that there was an arterial peripheral thromboemolism.At a third colonoscopy on (b)(6) 2021 the ulcer had reduced in size, but not resolved.On (b)(6) 021, the ulcer has not resolved.Phenprocoumon thus remains paused with the patient on subcutaneous heparin as anticoagulatory medication.The patient did not experience any symptoms since the interval between (b)(6) 2021 and (b)(6) 2021.A reevaluation via colonoscopy is planned in 6 weeks.

• Brand Name: 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: 12348666
• MDR Text Key: 267483591
• Report Number: 2916596-2021-04576
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/16/2022
• Device Model Number: 106524INT
• Device Lot Number: 7628796
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention