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

Catalog Number 104911

Device Problems Cut In Material (2454); Connection Problem (2900); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2017

Event Type  Injury  

Manufacturer Narrative

Device unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation.Approximate age of device - 5 years, 1 month.The device was returned for analysis.Evaluation is not complete.No further information was provided.A supplemental report will be submitted when the device analysis is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad).It was reported that the patient was explanted on (b)(6) 2017.During the procedure, a tear in the outflow graft bend relief was observed, and partial thrombosis was found in the outflow graft.The outflow graft had been damaged due to the bend relief causing abrasion and a tear, and thrombus was seen in that area.The patient was not symptomatic prior to the explant.The tear and thrombus were observed upon explant.

Manufacturer Narrative

The pump was returned assembled with the driveline cut approximately 11.5 inches from the pump housing; however, the distal portion of the driveline was not returned.Examination of the sealed inflow conduit, the sealed outflow graft, and the outlet elbow revealed no evidence of developed depositions or thrombus formations.The sealed outflow graft was returned severed at its hardware.A remnant of graft material that was left attached to the hardware appeared slightly frayed.A specific cause for this fraying could not be conclusively determined since the graft was cut at the time of the explant; however, the fraying could have resulted from the reported disconnection of the sealed outflow graft bend relief.The sealed outflow graft bend relief was also returned severed at its hardware.One of the bend relief¿s attachment tabs was slightly displaced, but there were no other unusual signs of wear or damage.Upon disassembly of the pump, examination revealed a deposition surrounding the bearing ball within the proximal side of the outlet stator.Its lack of concentric layering indicates that this deposition did not initially form in the outlet stator.The origin of this deposition could not be determined; however, its areas of slight denaturation suggest that it was present while the pump was supporting the patient.A specific cause for the development of this deposition and a correlation to the reported sealed outflow graft bend relief disconnect could not be conclusively determined.Upon removal of the observed deposition, the device was cleaned.The disassembled pump¿s bearings, rotor, and blood-contacting surfaces were microscopically examined and no anomalies were observed.Electrical continuity testing of the driveline did not reveal any discontinuities or shorts.The pump was reassembled and functionally tested under normal operating conditions using a mock circulatory loop.The data retrieved from this testing revealed normal pump power consumption and pressure values, and the device functioned as intended.Reports of disconnection of the bend relief from the sealed outflow graft have been addressed through the manufacturer's corrective/preventative action system, updated device labeling, an urgent medical device correction notice (2916596-2/24/12-001-c) and a sealed outflow graft bend relief collar (sobr collar) used to secure the bend relief to the sealed outflow graft and increase the assembly¿s resistance to forces that would tend to dislodge the bend relief.This design modification was approved in a pma supplement and has been implemented.Device 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 no deviations from manufacturing or quality assurance specifications.The manufacturer is closing the file on this event.

• 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: kathy reilly ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 9257380163
• MDR Report Key: 6396744
• MDR Text Key: 69645335
• Report Number: 2916596-2017-00487
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Catalogue Number: 104911
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 2916596-2/24/12-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 116