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

Model Number 104911

Device Problem Detachment Of Device Component (1104)

Patient Problem Thrombus (2101)

Event Date 10/06/2014

Event Type  Injury  

Event Description

The patient was implanted with a left ventricular assist device.The hospital reported the patient's pump had been shut-off since january and he was supported outpatient on inotropic therapy awaiting heart transplantation.On (b)(6) 2014, the decision was made to exchange his pump.The hospital reported visualization of a disconnected bend relief upon chest exploration/device removal.

Manufacturer Narrative

The reported pump thrombosis and subsequent pump being shut off was reported under mfr #2916596-2014-00206.The lvad was returned to the manufacturer for evaluation and is currently being analyzed.No further information is available at this time.A supplemental report will be submitted when the manufacturer's investigation is completed.

Manufacturer Narrative

The report of suspected thrombus was confirmed based on the evaluation of (b)(4); however, the report of a disconnected bend relief and a specific cause for the reported infection could not be conclusively determined.It was reported that upon device removal, the vad coordinator visualized a disconnected bend relief.The sealed outflow graft and bend relief were replaced during the exchange.However, the sealed outflow graft and bend relief were not returned for evaluation, and the reported disconnect could not be confirmed.Examination of the sealed inflow conduit revealed a strongly adhered deposition situated in the lumen of the inlet tube.The deposition appeared to be consistent with collapsed lining that developed in this area.The deposition appeared to have developed due to poor surface washing, caused by a low flow event or an interruption in flow through the pump.It was reported that the pump was turned off for an extended period of time, which likely contributed to the formation of the deposition.Examination of the rotor revealed a non-laminated deposition situated in between the blades of the rotor.The structure of the deposition suggested that it did not develop on the rotor.Although its origins cannot be conclusively determined, the deposition had areas that appeared denatured which is indication that the deposition was likely present while the pump was in operation.Examination of the pump bearings, rotor, and blood-contacting surfaces under a microscope, revealed no abnormalities that would have contributed to the formation of the thrombus.The pump was cleaned, reassembled, and functionally tested under loaded conditions using a mock circulatory loop.The retrieved data revealed normal pump power consumption comparable to the pump power consumption recorded during the manufacturing process, and the pump operated as intended.A review of the device history record revealed that the device met applicable specifications.No further information is available.The manufacturer is closing the file on this event.

Manufacturer Narrative

No further information is available at this time.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient expired on (b)(6) 2014 due to multisystem organ failure.According to the vad coordinator, the patient had an ongoing pump pocket infection and bacteremia prior to the patient's pump exchange on (b)(6) 2014.The infection was unable to be resolved through antibiotics.The center and the patient's family decided to withdraw support and the patient expired.There were no reported device issues on the patient's current pump.

Manufacturer Narrative

The user facility medwatch report was received from the (b)(4) registry.The user facility number was not provided.(b)(4).

Event Description

Additional information was received from the (b)(4) registry stating: air noted in lvad on ct of (b)(6) 2014.Decision made to replace pump.Additional information also included indicated that the patient expired on (b)(6) 2014 due to multisystem organ failure.Device function normal: yes.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
• Type of Device: 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: 4239452
• MDR Text Key: 5012261
• Report Number: 2916596-2014-01867
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2013
• Device Model Number: 104911
• Device Catalogue Number: 104911
• Device Lot Number: 110282
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/13/2014
• Is the Reporter a Health Professional?: No
• Device Age: 33 MO
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2011
• 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; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 82