MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

Model Number 106015

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Aortic Insufficiency (1715); Dyspnea (1816); Thrombus (2101)

Event Date 04/23/2018

Event Type  Injury  

Manufacturer Narrative

The elevated lactate dehydrogenase since (b)(6) 2018 referenced in this section was reported under medwatch mfr.Report # 2916596-2018-00365.The reference to the outflow graft stenting was reported under medwatch mfr.Report # 2916596-2018-00366.Approximate age of device ¿ 1 year and 9 months.The explanted pump is expected to be returned for evaluation.It has not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2016.It was reported that the patient presented to the clinic on (b)(6) 2018, and was admitted into the hospital due to complaints of nausea, increasing palpitations, shortness of breath, and chest pressure.On (b)(6) 2018, it was reported that elevated pump powers and flow estimation had been occurring.The patient had undergone outflow graft stenting for outflow graft narrowing on (b)(6) 2017.Since (b)(6) 2018 the patient¿s lactate dehydrogenase level had been elevated in the 12-1400 u/l range.International normalized ratio had been therapeutic.The patient was on aspirin and plavix.On (b)(6) 2018, the lvad clinician reported that the pump was exchanged with another manufacturer¿s pump on (b)(6) 2018, due to wide open aortic insufficiency and device thrombosis.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: a full evaluation of the device could not be conducted because it was not returned by the hospital.A correlation between the device and the reported event could not be conclusively determined.The instructions for use lists hemolysis as potential adverse events that may be associated with the use of heartmate ii left ventricular assist system.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 7538584
• MDR Text Key: 109105096
• Report Number: 2916596-2018-02159
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/10/2018

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: 05/31/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Other Device ID Number: 00813024011224
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 08/23/2018
• Supplement Dates FDA Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2016
• 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; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 101