MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE® VENTRICULAR ASSIST SYSTEM; CIRCULATORY ASSIST SYSTEM

Catalog Number 1104

Device Problems Detachment Of Device Component (1104); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 03/13/2014

Event Type  Death  

Event Description

Approximately seven and a half weeks after the implantation, the patient is reported to have experienced a decrease in his/her vad power consumption and flow estimates.From the report, it is unclear if the patient was at home, alone and/or in hospital at the time of this event.A computerized tomography (ct) revealed that the patient's outflow graft had become detached from his descending aorta and the patient expired.The patient's treating physician indicated that this was as a result of a severe generalized sepsis event.Investigation is ongoing.

Manufacturer Narrative

Additional information will be submitted within thirty (30) days of receipt.Device not returned.

Manufacturer Narrative

The device remains implanted in the patient (post mortem) and is not available for return to the manufacturer for analysis.Review of the manufacturing documentation confirmed that (b)(4) met all requirements for release.Review of the controller log files revealed a decline in estimated flows and power, as well as "low flow" alarms that correlate to the reported bleeding event.The most likely root cause of the sepsis event could not be determined based on the information provided.The most likely root cause of the bleeding event is the detached outflow graft.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Investigations of complaints with similar circumstances were reviewed.Infections are known risks in patients with percutaneous lines and/or implantable devices.They are a known potential complication associated with all patients implanted with vads and are multifactorial in etiology.No additional information will be forthcoming.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM
• Type of Device: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 310
• Manufacturer (Section G): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 310
• Manufacturer Contact: kathleen jacobson ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641562
• MDR Report Key: 3750763
• MDR Text Key: 4464776
• Report Number: 3007042319-2014-00341
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death