MAUDE Adverse Event Report: THORATEC CORP. HEARTMATE II LVAS, EUROPE; DSQ: LEFT VENTRICULAR ASSIST DEVICE

Model Number 102139

Device Problem Cut In Material (2454)

Patient Problem Unspecified Infection (1930)

Event Date 06/24/2014

Event Type  Injury  

Event Description

The pt was implanted with a left ventricular assist device (lvad).Approx 5 years post-implant, it was reported that the pt has an ongoing driveline infection.During a medication treatment of the pt's skin, the external portion of the driveline was damaged and the hospital covered the damage with tape.The pt remains in the hospital and in good condition.Additional info received indicated that the silastic sleeve was repaired by clinical specialist and the pt was placed on the transplant list due to his ongoing infection.

Manufacturer Narrative

The device remains implanted and in use by the pt.No further info is available at this time.A supplemental report will be submitted when the manufacturer's investigation is completed.

Manufacturer Narrative

The pump and the driveline remain in use with the patient.The report of damage to the external portion of the driveline was confirmed based on a submitted photo of the driveline; however, a specific cause for the reported driveline infection and a correlation to the device could not be determined.It was reported that the external portion of the patient's driveline was damaged during medical treatment and was repaired with tape.In addition, the driveline infection had resolved and the patient remains ongoing on vad support with no further issues reported.A review of device history records showed no deviations from manufacturing or qa specifications that would affect device function or performance.No further information is available.The manufacturer is closing its file on this event.

• Brand Name: HEARTMATE II LVAS, EUROPE
• Type of Device: DSQ: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORP.; pleasanton CA
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 7812720139
• MDR Report Key: 4008613
• MDR Text Key: 4951833
• Report Number: 2916596-2014-01091
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2011
• Device Model Number: 102139
• Device Catalogue Number: 102139
• Device Lot Number: 72161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/24/2014
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2014
• Date Manufacturer Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/11/2008
• 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): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 67