MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, EUROPE; LEFT VENTRICULAR ASSIST DEVICE

Catalog Number 106524INT

Device Problem Partial Blockage (1065)

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

Event Date 10/27/2017

Event Type  Injury  

Manufacturer Narrative

The patient¿s weight was not provided.Fda approval for heartmate 3 lvas was received on (b)(6) 2017.(b)(4).Approximate age of device ¿ 1 year, 7 months.The device is expected to be returned for analysis.It has not yet been received.The patient remains ongoing on lvad support with the replacement device.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 on (b)(6) 2017, the patient was admitted to the hospital due to symptoms of cardiac insufficiency.A ramp echocardiogram revealed the aortic valve opening every beat.A ct scan showed no flow through the outflow graft near the pump housing.The situation became worse the following day and thrombolysis was started without success.On (b)(6) 2017, the pump was exchanged.During the procedure, the surgeon disconnected the outflow graft from the pump and saw an occlusion of the outflow graft due to a compression between the outflow graft and the outflow graft bend relief.The outflow graft was reused with the new pump, and the bend relief was opened to remove all the thrombus material against the outflow graft, which released the pressure on the outflow graft.No thrombus was observed in the pump or in the outflow graft.The patient is stable in the intensive care unit.No additional information was provided.

Manufacturer Narrative

A potential cause for the report of low flow was confirmed through the ct scan images provided by the user facility.The ct images showed a potential area of outflow graft deformation under the outflow graft bend relief.The deformation of the outflow graft could have contributed to the report of low flows, which were captured on the lvad log files.Photographs of the outflow graft bend relief being cut open during the exchange procedure were also provided by the user facility, but the reported compression of the outflow graft under the bend relief was not visible.The outflow graft was not exchanged during the procedure and was not available for evaluation.The pump was returned assembled with the pump cable cut approximately at the pump end bend relief and the severed portion was not returned.Examination of the pump blood-contacting surfaces found no adhered depositions or thrombus formations.Visual inspection of the pump rotor found no evidence of dents or scratches.The pump was reassembled and operated on a mock circulatory loop and functioned as intended in accordance with manufacturing specification.The cause of the outflow graft deformation could not be conclusively determined.Lvad flow obstruction is listed in the instructions for use as a potential risk that may be associated with the use of the heartmate 3 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.

Manufacturer Narrative

Abbott has decided to initiate a voluntary field action for all lot numbers of heartmate iii distributed since september 2014.Internal investigation performed by abbott has determined there is a potential for an outflow graft occlusion due to twisting.Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.The root cause identification determined that bend relief rotation is inconsistently translated to the outflow graft hardware.A risk/benefit analysis was performed and it was determined that despite the potential for an outflow graft occlusion due to twisting, the associated residual risks are low and are considered acceptable.As a corrective action, consignees have been notified of the potential occlusion due to twisting.Additionally, abbott will continue to trend complaints related to this event based on original event description and/or results of product evaluation.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, 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: bob fryc ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7048419
• MDR Text Key: 92612508
• Report Number: 2916596-2017-02866
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 106524INT
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-1774-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR