MAUDE Adverse Event Report: THORATEC CORP. HEARTMATE II LVAS

Model Number 106015

Device Problems High Readings (2459); Device Dislodged or Dislocated (2923); Infusion or Flow Problem (2964)

Patient Problem Fall (1848)

Event Date 06/30/2014

Event Type  Injury  

Event Description

The patient was implanted with a left ventricular assist device (lvad).It was reported by hosp support that the patient had a recent fall and had to return to operating room for cannula repositioning on (b)(6) 2014.The patient now has been having increased flows and elevated power along with a decrease in the pulsatility index (pi).These events/parameter changes began following the pump repositioning procedure performed on (b)(6) 2014.On (b)(6) 2014, the mfr was informed via the device tracking system that the patient underwent a pump exchange from one lvad to another lvad on (b)(6) 2014.

Manufacturer Narrative

The explanted device was returned to the mfr for eval and is currently being analyzed.No further info is available at this time.A supplemental report will be submitted when the device analysis is completed.

Manufacturer Narrative

The customer reported cannula malposition and elevated ldh.The cannula malposition could not be confirmed as no images were submitted for evaluation.The report of increased flows, elevated power, and decreased pi following the pump repositioning procedure were confirmed during a submitted log file evaluation.The sealed inflow conduit, sealed outflow graft, and bend relief were not returned.The outflow elbow was returned detached from the pump.A deposition was observed during analysis which could have contributed to the report of elevated power.Evaluation revealed a red/white, tissue-like deposition in the outlet stator.The deposition surrounding the bearing ball within the proximal side of the outlet stator had a lack of laminated layering which indicates that it did not initially form in the outlet stator.While the origin of this deposition could not conclusively be determined, contact marks on the rotor bearing cup suggests that it was likely present while the device was supporting the patient.However, a cause for the formation of this thrombus could not be conclusively determined through this evaluation.Electrical continuity testing did not reveal any discontinuities or shorts.The pump was cleaned, reassembled and functionally tested under normal operating conditions and the device functioned as intended.Thrombus and hemolysis are listed in the instructions for use as potential adverse events that may be associated with the use of heartmate ii left ventricular assist system.Additionally, the patient¿s system controller was returned.The device was tested and found to function as intended.A review of the device history records revealed that the pump and system controller met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

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: elevated ldh, outlfow graft repositioned.

• Brand Name: HEARTMATE II LVAS
• 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: 4012438
• MDR Text Key: 20861659
• Report Number: 2916596-2014-01316
• 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: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 134062
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/08/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/30/2014
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2014
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 07/31/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/29/2015; 08/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2013
• 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 Weight: 90