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

Model Number 106524US

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

Patient Problems Air Embolism (1697); Death (1802); Multiple Organ Failure (3261)

Event Date 07/12/2019

Event Type  Death  

Manufacturer Narrative

Locking mechanism issue previously reported under mfr #2916596-2019-03141.Approximate age of device 17 days.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on: (b)(6) 2019.It was reported that the patient expired due to an air embolism from device locking issue and subsequently multi organ failure.Lvad support was withdrawn.Per information provided from clinical consultant was implanted and started without any problems and did not malfunction.The first pump had the locking issue which contributed to the air embolism that resulted in the patient's death.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(4), and the reported event could not conclusively be established through this evaluation.The account communicated that the new pump (b)(4) was implanted and started without any problems.The pump did not malfunction.The first pump (b)(4) had the problems that contributed to the outcome and has been returned for an evaluation (reported under mfr # 2916596-2019-03141).The account stated that the new pump would not be returned for an evaluation as the family declined.No further information was provided.The manufacturer is closing the file on this event.

• 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
• MDR Report Key: 8856824
• MDR Text Key: 153146868
• Report Number: 2916596-2019-03564
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

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: Health Professional
• Device Expiration Date: 03/16/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7000963
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 08/02/2019
• Supplement Dates Manufacturer Received: 08/23/2019
• Supplement Dates FDA Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Weight: 86