MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSISST) BYPASS

Model Number 106524

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

Patient Problems Edema (1820); Thrombus (2101)

Event Date 02/09/2018

Event Type  Injury  

Manufacturer Narrative

The heartmate 3 lvas was implanted during the (b)(6) clinical trial, ide# (b)(4).Fda approval for heartmate 3 lvas was received on 23 august 2017.The same device is used commercially and in the ongoing (b)(6) trial.The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4).No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that there was swelling noted in the left upper extremity.An ultrasonogram was completed and deep vein thrombosis (nonocclusive) in left subclavian vein was noted.Patient was already on anticoagulation.On (b)(6) 2018 another ultrasound was completed and shows occlusive thrombus in the distal left subclavian vein.(b)(6) 2018 radiology states left subclavian vein is only partially occluded, no intervention will be performed by the site.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(6), and the reported events could not be conclusively determined through this evaluation.The account reported that on (b)(6) 2018, the patient had slurring of words (dysarthria) and confusion.Neurology was consulted and a computed tomography (ct) scan of the head was done, which revealed that no acute process had occurred.On (b)(6) 2018, the patient was found to have dysphagia and needed an entech tube for medications and feedings.A percutaneous endoscopic gastrostomy (peg) tube was placed for feedings on (b)(6) 2018.Left upper extremity swelling was noted on (b)(6) 2020.An ultrasound (us) was done which revealed a deep vein thrombosis (dvt) that was nonocclusive, in left subclavian (sc) vein.The patient was reportedly already on anticoagulation at this time.On 11feb2018, the patient was found to have hypoxia and difficulty breathing.The rapid response team (rrt) was called and the patient was intubated and then transferred back to the intensive care unit (icu).It was determined that the patient had hypoxic, hyper-carbic respiratory failure which was most likely caused from aspiration pneumonitis.A right heart catheterization (rhc) was obtained to evaluate hemodynamics.On (b)(6) 2018, a tracheostomy (trach) was placed on (b)(6) 2018, another ultrasound done which showed an occlusive thrombus in the distal, left subclavian vein.On (b)(6) 2018, radiology was consulted and stated that the left subclavian vein was only partially occluded.Per the patient¿s doctor, no intervention was to be performed.The events reportedly remained ongoing.The patient remained ongoing on heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), until (b)(6) 2018 when the patient ultimately expired.The device was not returned for evaluation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 21apr2017.The heartmate 3 lvas ifu and the heartmate 3 lvas patient handbook are currently available.Section 1 of the ifu lists respiratory failure, other neurological event (not stroke related), and venous thromboembolism as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 of the ifu also lists thromboembolism and neurological dysfunction as potential late postimplant complications.Additionally, section 6, under ¿anticoagulation¿, provides the recommended anticoagulation regimen, including inr range, as well as suggested anticoagulation modifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10740899
• MDR Text Key: 213216342
• Report Number: 2916596-2020-05105
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 106524
• Device Catalogue Number: 106524
• Device Lot Number: 5947097
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 83