MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA; VENTRICULAR (ASSISST) BYPASS

Catalog Number 106015

Device Problems Partial Blockage (1065); Material Twisted/Bent (2981)

Patient Problems Thrombus (2101); Heart Failure (2206)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

Approximate age of device - 2 years, 11 months.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 left ventricular assist device (lvad) on (b)(6) 2015.It was reported that patient was hospitalized with symptoms of heart failure (hf).Evaluation indicated a potential outflow graft obstruction or twist.Patient subsequently underwent pump exchange on (b)(6) 2018.A thrombus was observed inside the outflow graft.Additional information was requested but not yet provided.

Manufacturer Narrative

Device evaluation: a correlation between the device and the reported event could not be conclusively determined through this evaluation.The report of outflow graft thrombus could not be confirmed through this evaluation.The evaluation of the device did not reveal any device-related issues.The pump was returned assembled with the driveline cut approximately 2.5¿ from the pump housing and the distal portion was not returned.The sealed inflow conduit was returned detached from the pump housing.The sealed outflow graft conduit was returned attached to its respective pump port.The outflow bend relief and collar were detached from the remaining outflow hardware.Upon disassembly, visual inspection of the pump blood-contacting surfaces, including the returned portion of the outflow graft, revealed no evidence of adhered depositions or thrombus formations.Examination of the pump bearings, rotor, and blood-contacting surfaces under a microscope did not reveal any anomalies related to wear or damage.Electrical continuity testing of the returned portion of the driveline did not reveal any discontinuities or shorts.Functional testing of the pump under normal operating conditions revealed normal pump power consumption and pressure values comparable to the data recorded during the manufacturing process.The pump operated as intended.The implant kit was shipped with the heartmate ii lvas ifu.Section 1 lists device thrombosis as an adverse event that may be associated with the use of the hmii lvas.Section 6 explains indications of thrombus and potentially affected pump parameters, as well as how to respond to such an event.Section 6 outlines recommended anticoagulation therapy and inr range.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.

Manufacturer Narrative

Section d1: additional information.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 7577438
• MDR Text Key: 110333500
• Report Number: 2916596-2018-02341
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2020

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: Lay User/Patient
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 106015
• Other Device ID Number: 813024011224(2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 06/07/2018
• Supplement Dates Manufacturer Received: 08/13/2018; 02/19/2020
• Supplement Dates FDA Received: 08/31/2018; 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 91