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	Death (1802); Unspecified Infection (1930)
Date of Event	06/28/2014
Type of Reportable Event	Death
Additional Manufacturer Narrative
Reference mfr report # 2916596-2019-00841 for the report of the other pvad, serial number (b)(4), implanted for left ventricle support.Approximate age of device ¿ 82 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 supported with two paracorporeal ventricular assist devices (pvads) for biventricular support on (b)(6) 2014.It was reported that the patient expired on (b)(6)2014.The cause of expiration was long standing pseudomonas driveline infection with bacteremia.No autopsy was performed and the devices were not explanted.Pvad serial number (b)(4) was implanted for left ventricular support and pvad serial number (b)(4) was implanted for right ventricular support.
Additional Manufacturer Narrative
Investigation summary: a specific cause for the reported driveline infection cannot be conclusively determined.The patient expired on (b)(6) 2014 due to a long-standing pseudomonas driveline infection and bacteremia.No autopsy was performed, and the device was not explanted.No product available for investigation.The vad instructions for use lists infection as an adverse event that may be associated with the use of the vad system.The ifu also provides information regarding the prevention of infection the relevant sections of the device history records for pvad serial number (b)(4) (documents (b)(4)) were reviewed and showed no deviations from manufacturing or quality assurance specifications no further information was provided.The manufacturer is closing the file on the 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: 8364875
• Report Number: 2916596-2019-00887
• Device Sequence Number: 1606635
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

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: 08/31/2016
• Device Model Number: 14086-2550-000
• Device Catalogue Number: 14086-2550-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 02/24/2019
• Supplement Report FDA Received Date: 05/10/2019
• 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: 62 YR
• Patient Weight: 82