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

Catalog Number 104911

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombus (2101)

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

Approximate age of device ¿ 5 years and 4 months.  no device-related issues were identified through the evaluation of the returned pump.However, depositions were observed on several of the blood-contacting surfaces during the analysis.The pump was returned assembled with the driveline cut approximately 7.5 inches from the pump housing.The distal portion of the driveline was not returned.The sealed inflow conduit (inlet tube, flex section, and inlet elbow) was returned attached to the proximal pump port.The outlet elbow was returned attached to the distal pump port.The sealed outflow graft conduit was returned attached to the pump outlet elbow.The bend relief was returned not secured to the graft attachment.Examination of the sealed inflow conduit found depositions in the inlet tube and the inlet elbow.The depositions were thin, flat, and adhered to the textured surfaces.There appeared to be minimal occlusion of the blood flow path.The cause of the depositions could not be conclusively determined.The patient was reported to have been routinely transplanted and the deposition did not appear to have contributed to any device related issues.Examination of the sealed outflow conduit and pump blood contacting surfaces revealed no depositions or thrombus formations.Visual inspection of the pump bearings and bearing cups under a microscope found no anomalies related to wear or damage.Examination of the returned portion of the percutaneous lead found it to be unremarkable.Electrical continuity testing of the wires found no discontinuities or shorts.The pump was reassembled and operated on a mock circulatory loop and functioned as intended.Thrombosis is listed in the instructions for use as a potential adverse event that may be associated with the use of the heartmate ii left ventricular assist system.A review of the device history records revealed that the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2012.On (b)(6) 2018 the patient received a transplant.There were no issues reported with the pump.During investigation of the returned explanted pump, thrombus was found within the device.

• 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: bob fryc ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7649197
• MDR Text Key: 112868066
• Report Number: 2916596-2018-01775
• 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: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2014
• Device Catalogue Number: 104911
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2018
• Date Device Manufactured: 07/31/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 115