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

Model Number 103695

Device Problems Leak/Splash (1354); Cut In Material (2454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2014

Event Type  malfunction  

Manufacturer Narrative

The pump remains in use supporting the pt.No further info is available at this time.A supplemental report will be submitted when the mfr's investigation is completed.

Event Description

The pt was implanted with a left ventricular assist device (lvad).It was reported by the biomedical engineer that this pt had a previous slit in the silastic of the driveline, externally, and after showering, the pt noticed dark yellow fluid oozing from the slit on the driveline.The pt was asymptomatic, no alarms and the pump parameters were within normal limits.The mfr's technical service group rec'd x-rays of the implanted portion of the percutaneous lead and the implanted pump for review and reported that the images were not clear but no gross anomalies of the percutaneous lead were noted.The pt remains ongoing.

Manufacturer Narrative

Device evaluation: the pump was returned assembled with the percutaneous lead (lead) cut approximately 3 inches from the pump housing and the rest of the lead was also returned.The sealed inflow conduit, sealed outflow graft and outflow bend relief were not returned.The outflow elbow was returned attached to the pump.The evaluation of the disassembled pump revealed no deposition within the pump.The reported slit in the silastic sleeve on the external portion of the lead was confirmed upon examination of the lead.The pump end bend relief was fully intact.The examination of the lead also revealed damage to the silastic sleeve on the internal portion of the lead; however, the damage was consistent with tool damage and was possibly caused during the explant.A root cause for the fluid leakage was not determined.A review of device history records showed no deviations from manufacturing or qa specifications.No further information is available.The manufacturer is closing its file on this event.

Event Description

Additional information: the patient underwent a pump exchange on (b)(6) 2015 to address the issue of fluid coming out of the slit in the external portion of the percutaneous lead (reference medwatch # 2916596-2015-00418).

Manufacturer Narrative

The user facility number was not provided.(b)(4).

Event Description

Additional information was received from the intermacs registry stating: patient came to clinic with complaints of liquid come out of slits in driveline.It was determined to be biological in nature.Her pump was of the generation where the inside pump strain relief could have broken so pump was exchanged and returned to company for evaluation.

• Brand Name: HEARTMATE II LVAS
• 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: 3822696
• MDR Text Key: 19453043
• Report Number: 2916596-2014-00221
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Model Number: 103695
• Device Catalogue Number: 103695
• Device Lot Number: 94251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/25/2014
• Device Age: 43 MO
• Event Location: Home
• Date Report to Manufacturer: 01/25/2014
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2010
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 128