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

Model Number	106524US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Death (1802); Multiple Organ Failure (3261)
Date of Event	07/12/2019
Type of Reportable Event	Death
Additional 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 or Problem 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patient expired due to an air embolism from device locking issue and subsequently multi organ failure.Lvad support was withdrawn.Per information provided from clinical consultant was implanted and started without any problems and did not malfunction.The first pump had the locking issue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.
Additional 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
• Common Device Name: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 8856824
• Report Number: 2916596-2019-03564
• Device Sequence Number: 2352862
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 68 YR
• Patient Weight: 86