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 Diarrhea (1811); Dyspnea (1816); Fall (1848); Hemorrhage, Subarachnoid (1893); Unspecified Infection (1930)

Event Date 04/11/2020

Event Type  Injury  

Manufacturer Narrative

Patient weight has been requested but not yet provided.No further information was provided.A supplemental report will be provided when the manufacturer's investigation is complete.

Event Description

It was reported that the patient presented with dyspnea, altered mental status, and diarrhea after falling at home.They were admitted and had a head ct, which showed a subarachnoid hemorrhage which was likely related to the fall.Neurology was consulted and coumadin was held for 2 weeks.It was restarted without issue and the patient had no neurological deficits.The patient was also noted to have a sternal wound infection with spontaneous drainage that was (b)(6) for (b)(6).A tagged white blood cell scan showed infection around the driveline.The patient was treated with iv antibiotics and taken to the operating room (or) for incision and drainage (i&d) of the wound, as well as a vacuum assisted closure (vac) placement.They were then taken back to the operating room with plastic surgery and had an omental flap.The patient was then treated with a course of iv antibiotics and transitioned to oral antibiotic which would be continued, likely lifelong.The patient was considered stable from an infectious standpoint.There were no alarms for the event.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct relationship between heartmate 3 lvas, serial number (b)(6), and the reported events could not be conclusively established through this evaluation.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.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 or quality assurance specifications.The implant kit was shipped to the customer on (b)(6) 2019.Review of the sterilization and packaging documentation in the device history records found no deviations from manufacturing specifications.The current revision of the heartmate 3 lvas ifu is rev.C.This ifu lists bleeding as an adverse event that may be associated with the use of heartmate 3 left ventricular assist system.The section entitled ¿ongoing patient assessment and care¿ provides information regarding anticoagulation, including recommended inr values, and the suggested anticoagulation modifications in the event that there is a risk of bleeding.This document also lists infection as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.Care instructions in reference to preventing infection are provided throughout this ifu, including sections titled "caring for the driveline exit site" and "controlling infection.".

• 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: 10712874
• MDR Text Key: 212334029
• Report Number: 2916596-2020-05174
• 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: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7320757
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 27 YR