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 Bacterial Infection (1735); Death (1802); Hemorrhage, Cerebral (1889); Sepsis (2067)

Event Date 10/14/2020

Event Type  Death  

Manufacturer Narrative

The patient's ongoing infection was previously reported under reported under mfr #2916596-2019-02075 and mfr # 2916596-2019-02072.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 due to sepsis; e coli/pseudomonas aerginosa.The patient had an ongoing pump pocket infection and was on warfarin therapy.The patient had a large intracerebral hemorrhage that lead to the family choosing comfort measures and stopping the pump, stopping pressors, and withdrawing ventilatory support and extubating.The device was not explanted and will not be returned.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported events.And ultimate patient outcome, as well as a direct correlation to heartmate ii left ventricular assist system (lvas), serial number (b)(4), could not conclusively be determined through this evaluation.It was reported via the patient outcome, that the patient expired on (b)(6) 2020, due to sepsis.The patient reportedly, had an ongoing pump pocket infection.Additional information indicated, that the patient experienced a large intracerebral hemorrhage (ich).After which, the patient¿s family ultimately decided to enact comfort measures.There were no alarms associated with this event.It was believed, that the device had operated as intended.The device was not explanted.And will not be returned for evaluation.The relevant sections of the device history records for (b)(4) were reviewed.And showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on (b)(6) 2014 via customer order (b)(6).The current heartmate ii lvas instructions for use (ifu) lists, driveline or pump pocket infection, sepsis, stroke, and death as adverse events, that may be associated with the use of heartmate ii left ventricular assist system in section 1 ¿introduction¿.Section 6 under "anticoagulation", also contains information regarding the recommended anticoagulation therapy and inr range that should be maintained for patients using the device.As well as the recommended anticoagulation modifications in the event there is a risk of bleeding.Care instructions regarding infection are also provided in the ¿patient care and management¿ section of this ifu.The current heartmate ii lvas patient handbook also contains care instructions for preventing infection which are outlined in various sections of this document.No further information was 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
• MDR Report Key: 11011036
• MDR Text Key: 221503713
• Report Number: 2916596-2020-05857
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2016
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR
• Patient Weight: 94