MAUDE Adverse Event Report: THORATEC CORPORATION PVAD; VENTRICULAR (ASSIST) BYPASS

Model Number	14086-2550-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/03/2001
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Death is reported under the l pvad 2916596-2023-00514.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the patient passed away.The cause of death is unknown.Whether the outcome was device or therapy related was not provided by the customer.An autopsy was not performed.The pump was not explanted and will not return for evaluation.The customer reported that no additional information could be provided.
Additional Manufacturer Narrative
Section a: date of birth could not be provided.Manufacturer's investigation conclusion: a direct correlation between the ventricle assist device (vad), serial number: (b)(6), and the patient's outcome could not be conclusively determined through this evaluation.The device history records for the vad serial number: (b)(6) were not reviewed as the product is no longer manufactured by abbott and no specific device-related adverse events were reported.The vad instructions for use (ifu) is currently available.Although no device related issues were reported, the ifu lists potential adverse events, including death, that may be associated with the use of the ventricular assist device.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: PVAD
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 16296115
• Report Number: 2916596-2023-00785
• Device Sequence Number: 18015421
• Product Code: DSQ
• UDI-Device Identifier: 00813024012009
• UDI-Public: 00813024012009
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P870072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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 Model Number: 14086-2550-000
• Device Catalogue Number: 20099-2575-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 55 KG