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 Ischemia (1942); Septic Shock (2068); Cardiogenic Shock (2262); Respiratory Acidosis (2482); Respiratory Failure (2484); Heart Failure/Congestive Heart Failure (4446)

Event Date 09/12/2021

Event Type  Death  

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 passed away on (b)(6) 2021 due to septic shock, bacteremia, cardiogenic shock and acidosis respiratory failure shock.Whether the outcome was device or therapy related was not provided.It is unknown if the device will be returned for evaluation.No additional information provided.

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 patient expired on (b)(6) 2021 due to septic shock, bacteremia, cardiogenic shock, and acidosis respiratory failure shock.The heartmate 3 lvad, serial number (b)(6) , was not returned for analysis.The heartmate 3 lvas ifu, is currently available.Section 1 ¿introduction¿ of this document lists sepsis, respiratory failure, and death as adverse events that may be associated with the use of the heartmate 3 lvas.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The relevant sections of the device history records for the percutaneous lead were also reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on (b)(6) 2021.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

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

Event Description

The patient had a right ventricular assist device (rvad) placed on (b)(6) 2021 (protek duo).The patient also required continuous renal replacement as patient was end stage renal disease on hemodialysis prior to heartmate 3 implant.Additionally, the patient required exploratory laparotomy for mesenteric ischemia with open abdomen.The patient developed worsening shock and care was eventually withdrawn.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 12587341
• MDR Text Key: 275123243
• Report Number: 2916596-2021-05563
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8065712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 119 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American