MAUDE Adverse Event Report: THORATEC CORPORATION PVAD; VENTRICULAR ASSIST DEVICE ¿ PARACORPOREAL PUMP

Model Number	14086-2550-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Death (1802)
Date of Event	08/25/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
This report is for the right pvad.The left pvad was reported under mfr.Report # 2916596-2019-04446.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) 2017.It was reported that patient expired from a hemorrhagic stroke.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: a correlation between the device and the reported event cannot be conclusively determined.It was reported that the patient expired on (b)(6) 2019 due to a large hemorrhagic stroke.The device was not explanted and is not available for investigation.The vad instructions for use lists bleeding and stroke as adverse events that may be associated with the use of the vad system.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: PVAD
• Common Device Name: VENTRICULAR ASSIST DEVICE ¿ PARACORPOREAL PUMP
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 9011821
• Report Number: 2916596-2019-04182
• Device Sequence Number: 2192527
• Product Code: DSQ
• UDI-Device Identifier: 00813024012009
• UDI-Public: 00813024012009
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P870072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Model Number: 14086-2550-000
• Device Catalogue Number: 14086-2550-000
• Device Lot Number: 13735
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 10/30/2019
• 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: 59 YR
• Patient Weight: 80