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

Catalog Number 104912

Device Problems Partial Blockage (1065); Detachment Of Device Component (1104); High Readings (2459); Device Dislodged or Dislocated (2923)

Patient Problems Heart Failure (2206); Obstruction/Occlusion (2422)

Event Date 08/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Approximate age of device ¿ 4 years, 5 months.The device was returned for analysis.The evaluation is not complete.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is complete.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2012.It was reported that on (b)(6) 2016, the patient was admitted to the hospital due to elevated pump powers.An echocardiogram showed that there was no flow through the pump.Extracorporeal membrane oxygenation (ecmo) was initiated to stabilize the patient.A ct scan showed a completely thrombosed outflow graft and a decision to perform a pump exchange was made.It was reported that during the explant of the pump, the surgeon observed that the outflow graft bend relief was disengaged and had kinked the outflow graft, which appeared to be the reason that the pump and the outflow graft thrombosed in such a short time.The outflow graft was also reported to have a rupture in it that was located directly proximal to the area where the outflow graft bend relief connects to the outflow graft conduit.The complete lvad system was exchanged.No further information was provided.

Manufacturer Narrative

The evaluation of the returned device as well as the photos submitted by the hospital confirmed the report of a disengaged sealed outflow graft bend relief, a distorted/torn sealed outflow graft, and device thrombosis associated with a low flow condition.The sealed outflow graft conduit was returned with the bend relief detached from the graft attachment and the outflow graft was returned in two pieces.Examination of the proximal severed portion of the sealed outflow graft revealed a tear in the material adjacent to the graft attachment, which appeared consistent with abrasion against the metal bend relief attachment clip.Examination of the inlet tube, inflow graft, graft attachment, and returned portions of the outflow graft revealed depositions of loosely clotted blood and tissue-like clotted blood.The inlet elbow was occluded with loosely clotted blood and grainy denatured blood.Upon disassembly of the returned device, soft depositions of grainy denatured blood as well as hard, denatured blood were found throughout the body of the pump.The hard depositions around the body of the rotor, on the lumen of the blood tube, and surrounding the outlet bearing ball were strongly adhered to the blood-contacting surfaces.All of the observed depositions appeared to have developed as a result of poor surface washing due to a low flow situation or interruption in flow through the pump.The disengagement of the sealed outflow graft bend relief and subsequent distortion and perforation of the outflow graft would have caused inadequate flow through the pump, resulting in thrombus formation.The depositions found in the pump would have caused increased rotor drag, resulting in the reported elevation in pump power.Visual inspection of the pump bearings, rotor, and blood-contacting surfaces did not reveal any anomalies.Electrical continuity testing of the returned portion of the percutaneous lead 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 and the pump operated 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.The event occurred in (b)(6) where the pump was implanted 4 days after the correction notification and prior to the ce mark approval for the sobr collar.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.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.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS, EUROPE
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564071
• MDR Report Key: 5959173
• MDR Text Key: 54992117
• Report Number: 2916596-2016-01814
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 08/23/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2013
• Device Catalogue Number: 104912
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2016
• Initial Date FDA Received: 09/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2011
• 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: 51 YR
• Patient Weight: 75