MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS; LEFT VENTRICULAR ASSIST DEVICE

Catalog Number 103695

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

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

Event Date 02/05/2015

Event Type  Injury  

Event Description

The patient was implanted with a left ventricular assist device (lvad).It was reported that the patient¿s pump was exchanged due to fluid coming out of a slit in the external portion of the percutaneous lead for which a cause could not be found.The inflow conduit and outflow graft were not replaced.There was reportedly a ¿fairly decent amount of fluid that continuously flowed." it was reported that during the exchange, there was no obvious break noted at the strain relief.

Manufacturer Narrative

Approximate age of device ¿ 4 years and 7 months.The pump was returned to the manufacturer for analysis.The evaluation is not yet completed.No further information is available at this time.A supplemental report will be submitted when the device analysis is completed.Placeholder.

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.

• Brand Name: HEARTMATE II LVAS
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 781272-013
• MDR Report Key: 4574473
• MDR Text Key: 5548454
• Report Number: 2916596-2015-00418
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 103695
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 58