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

Model Number 106524US

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

Patient Problems Hemorrhage, Subarachnoid (1893); Ischemia (1942); Thrombus (2101); Weakness (2145); Blood Loss (2597); Ptosis (2620); Thromboembolism (2654); Hemorrhagic Stroke (4417); Gastrointestinal Hemorrhage (4476)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient had lvad implantation on (b)(6) 2019 via median sternotomy.There were post-operative complications such as stroke (revealed by ct scan and neuro evaluation), right upper/lower extremity ischemia, gastrointestinal bleed (revealed by esophagogastroduodenoscopy), and subarachnoid hemorrhage (revealed by ct scan).For the limb ischemia, fleeting pulses in patient's right lower extremity was seen by vascular surgery and taken for right brachial artery thrombectomy, bovine patch angioplasty, and exploration.Symptoms include weakness/speech difficulties, left eye ptosis, left side facial droop, and pronator drift.The patient was given aspirin and rehabilitation for stroke and limb ischemia and digoxin and omega-3 for gi bleed.The limb ischemia was likely from ecmo/impella cannula.A low flow alarm was present on (b)(6) 2020.There was concern for pump thrombosis.

Manufacturer Narrative

Correction to b5: the patient's low flows occurred on (b)(6)2020 and did not occur during this event.Manufacturer's investigation conclusion: a direct relationship between the device and the reported cerebrovascular accident (cva), peripheral thromboembolism, gastrointestinal bleeding, and subarachnoid hemorrhage (sah) could not be conclusively determined through this evaluation.The patient remains ongoing on ventricular assist device (vad) support.Review of the available device history records showed no deviations from manufacturing or qa specifications.The implant kit was shipped to the customer on 29apr2019.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) lists stroke, venous thromboembolism, and bleeding as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.This document also lists thromboembolism as a potential late postimplant complication.This ifu provides information regarding anticoagulation, including recommended international normalized ratio (inr) values.The ifu explains that the low flow hazard alarm will be triggered when pump flow is less than 2.5 liters per minute (lpm) and notes that changes in patient conditions can result in low flow.This ifu also describes all system alarms and the recommended actions associated with them.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Correction: the patient was not diagnosed with pump thrombosis in (b)(6)2020.Lactate dehydrogenase was within normal limits, blood pressure was stable, and pump parameters were stable aside from one lone low flow event that did not last long enough to trigger an alarm.

• 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: 10809090
• MDR Text Key: 215288490
• Report Number: 2916596-2020-05276
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

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: Health Professional
• Device Expiration Date: 02/19/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6938226
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 50