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.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate ii left ventricular assist system (hm3 lvas), serial number: (b)(6), and the reported events and patient outcome could not be conclusively established through this evaluation.It was reported by the account that the patient passed away on (b)(6) 2021 due to septic shock.Additional information received from the customer indicated that the patient went into respiratory arrest and had aspiration pneumonia.The patient had also presented with decreased hemoglobin and melena and gastrointestinal (gi) bleeding was confirmed via esophagogastroduodenoscopy (egd).The device was reported to have operated as expected and the death was not considered to be device related.The device will not be returned for evaluation.The relevant sections of the device history record for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii left ventricular assist system (hmii lvas) instructions for use (ifu) is currently available.Section 1, ("introduction") lists potential adverse events that may be associated with the use of the hm3 lvas, including death, sepsis, respiratory failure, and bleeding.Section 6, (¿patient care and management¿), provides information regarding anticoagulation, including the recommended international normalized ratio (inr) values.No further information provided.The manufacturer is closing the file on this event.

• 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
• MDR Text Key: 281971743
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 02/22/2022
• Supplement Dates FDA Received: 02/23/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Life Threatening; Death
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American