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 Death (1802); Hemorrhage, Subarachnoid (1893); Thromboembolism (2654)

Event Date 10/11/2020

Event Type  Death  

Manufacturer Narrative

Previous stroke was reported under mfr # 2916596-2020-05273.Previous bleeding on (b)(6) 2020 reported under mfr # 2916596-2020-05511.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that patient had a sudden onset of gargled speech.Patient was admitted to hospital.Head ct (computed tomography) showed diffuse subarachnoid hemorrhage in left cerebral hemisphere.Neuro was consulted, anticoagulation held and patient received vitamin k at outside hospital prior to transfer to implanting center.The international normalized ratio (inr) at time of event was 2.7.Patient remained in neuro intensive care unit on every 2-hour neuro checks.Patient opened eyes spontaneously but did not follow commands.Supportive care continued.Patient with previous stroke following lvad implant on (b)(6) 2020 in the same area, which presented at that time with aphasia.Recent supratherapeutic inr (3.7 on (b)(6) 2020) and then subtherapeutic inr as outpatient due to hematuria and suspected gastrointestinal bleeding (gib) (1.6-1.8 from 24sep2020 to 03oct2020).Patient was admitted (b)(6) 2020 for gib evaluation which wasn't felt to be urgent and discharged on (b)(6) 2020 with lovenox bridge.The treatment administered was vitamin k and kcentra for inr reversal (2.7 on admit), serial ct and monitoring.Work up for mobility/thrombus of aortic valve which did note 1 immobile leaflet, digital subtraction angiography (dsa) negative for aneurysm.Patient was intubated given concern for seizures on antiepileptic prophylaxis, evolving subarachnoid hemorrhage (sah) when heparin resumed after anticoagulation hold for 10 days and transitioned to comfort/palliative care per family¿s wishes.Additional information stated that patient expired on (b)(6) 2020 per family wishes after transitioning to comfort care.The device was not explanted and it will not be returned.

Manufacturer Narrative

Section d5: correction.Section h6 (patient code): correction.Manufacturer's investigation conclusion: a specific cause for the reported events, as well as a direct correlation to the heartmate 3 lvas, serial number (b)(4), could not conclusively be determined through this evaluation.The relevant sections of the device history records for (b)(4) were reviewed, and showed no deviations from manufacturing or quality assurance specifications.The pump was shipped on 15jul2020.The heartmate 3 lvas ifu lists: peripheral thromboembolism, bleeding, stroke and death as adverse events, that may be associated with the use of the heartmate 3 left ventricular assist system.The ifu lists thromboembolism as a potential late postimplant complication.And provides information regarding anticoagulation, including the recommended inr values.No further information was provided.The manufacturer is closing the file on this event.

• 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: 10849345
• MDR Text Key: 216553754
• Report Number: 2916596-2020-05264
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/12/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7550516
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 72 YR
• Patient Weight: 97