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

Model Number 106524US

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Infarction, Cerebral (1771); Embolus (1830); Cardiac Tamponade (2226); Blood Loss (2597)

Event Date 11/20/2020

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 the patient with cardiac tamponade had flows decreased to 2 liters and pulsatility index increased to 9.One liter of blood and a clot from raw surfaces in mediastinum were observed.The patient had a left facial droop and left upper extremity weakness at 10:20 am on (b)(6) 2020.They were having difficulty reaching for things but did not have those symptoms prior to hospitalization.A nurse reported garbled speech over the weekend but that improved.A computed tomography scan showed subacute ischemic stroke in the right insula and right frontal operculum and a remote lacunar infarct of right cerebellum with high attenuation of posterior right m2 segment.This was reported as likely a 2/2 embolus from recent the pump placement vs other embolic source.It was less likely atherosclerosis.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported events, as well as a direct correlation to heartmate 3 lvas, serial number (b)(6), could not conclusively be determined from this evaluation.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).No product is available for investigation.The relevant sections of the device history records for (b)(6), were reviewed and showed no deviations from manufacturing and quality assurance specifications.The pump was shipped on (b)(6) 2020.The current heartmate 3 lvas ifu lists pericardial fluid collection and stroke adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 ¿patient care and management¿ 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: 11038146
• MDR Text Key: 222389271
• Report Number: 2916596-2020-05987
• 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,study
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/06/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7563520
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 88