MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS

Model Number 106015

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

Patient Problems Pneumonia (2011); Septic Shock (2068); Respiratory Arrest (4461); Gastrointestinal Hemorrhage (4476)

Event Date 06/13/2021

Event Type  Death  

Manufacturer Narrative

No further information was provided. A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient passed away due to septic shock. The patient went into respiratory arrest with a procedure and had aspiration pneumonia as well as a gastrointestinal (gi) bleed. The gi bleed was confirmed through an esophagogastroduodenoscopy (egd). The patients hemoglobin (hgb) dropped and they had melena. It was reported that the death was not device related as it operated as expected and the infection was gram- (b)(6) pneumonia.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• 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: 12966965
• Report Number: 2916596-2021-07030
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/30/2018
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American
• Patient Outcome(s): Life Threatening; Death