MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

Catalog Number 106524

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

Patient Problems Death (1802); Unspecified Infection (1930)

Event Date 03/04/2017

Event Type  Death  

Manufacturer Narrative

The initial submission of this event was reported by the manufacturer under mfr report # 2916596-2018-01392.This report is being submitted as additional information.The heartmate 3 lvas was implanted during the momentum 3 clinical trial, ide# (b)(4).Fda approval for heartmate 3 lvas was received on 23 august 2017.The same device is used commercially and in the ongoing momentum 3 trial.The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4).Age of device: 1 year, 4 months.Manufacturer's investigation conclusion: the pump was not explanted and was therefore not available for evaluation.A specific cause for the reported infection could not be determined through this evaluation.Moreover, a direct correlation between the device and the reported intracranial hemorrhage and subsequent patient outcome could not be determined through this evaluation.Infection (including localized and pump pocket or pseudo pocket), bleeding and stroke are listed as potential adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient was implanted with left ventricular assist device (lvad) on (b)(6) 2016.It was reported that the patient had a known history of achromobacter infection from sternal wound.The patient recently completed course of zosyn from (b)(6) 2017.The patient was subsequently started on minocycline.The peripherally inserted central catheter (picc) line remained in place.Per infectious diseases specialist, picc line was removed and the patient was started on zosyn as this bacterial strain remained sensitive to zosyn.The patient had presented to emergency department (ed) with weakness on (b)(6) 2018, but was discharged home the same day.The patient called to come back after blood culture (bcx) from the emergency department visit turned positive for achromobacter, similar infection as prior.Ct chest revealed a small amount of fluid around the outflow cannula.Per ct surgery review, the patient was not deemed an appropriate candidate for pump exchange.Unfortunately, blood cultures continued to remain positive despite treatment with intravenous zosyn concerning that bacteremia would be difficult, if not impossible, to clear without surgical intervention.On (b)(6) 2017, the patient expired due to intracranial hemorrhage.It was reported that the cause of death was not device related.An autopsy was not performed.No additional information was received.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 8205767
• MDR Text Key: 131694929
• Report Number: 2916596-2018-05843
• Device Sequence Number: 1
• Product Code: DSQ
• 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,study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 106524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR
• Patient Weight: 116