MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG; CENTRIMAG BLOOD PUMP

Catalog Number 102953

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Death (1802); Blood Loss (2597); Multiple Organ Failure (3261)

Event Date 12/11/2013

Event Type  Death  

Manufacturer Narrative

Approximate age of device: 2 days (calculated from date of implant to date removed).No additional 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) on (b)(6) 2013.Once the lvad support was initiated and functioning normally, the patient began to have issues with right ventricular function.Right ventricle extracorporeal circulatory support was initiated.As the patient was being transferred from the operating room table to a bed, the outflow cannula for the right ventricle support pump became dislodged from the pulmonary artery resulting in the outflow from the rvad entering the patient¿s mediastinum.The patient¿s chest, which had been packed and covered with an ioban dressing, was quickly accessed and the pulmonary artery cannula was replaced.The extracorporeal circulatory support cannulae had been secured to the skin with multiple sutures and exited out of the superior portion of the sternal incision.During the event, the patient was hypotensive and there was a 15 minute down time.Multiple blood products were administer via rapid infuser.Once the patient was volume resuscitated the rvad and lvad flows stabilized.The patient reportedly recovered enough to be weaned off rvad support after 2 days.However, the patient's neurologic status never improved.Neurology consult found the patient had poor neurologic/brain function and a poor prognosis for recovery.Additionally, the patient developed acute renal failure on top of chronic renal failure, requiring dialysis.The patient was also ventilator dependent due to respiratory failure.The patient continued to experience right ventricular dysfunction requiring further increase in inotropic support.After every attempt was made possible to correct each problem, the patient ultimately succumbed to multisystem organ failure.The patient decided to withdraw care, and several days after the holidays, the family decided to withdraw care.On (b)(6) 2014, all devices were turned off, and the patient quickly expired, with family at the bedside.It was reported that there were no device issues associated with the patient outcome and the devices had operated as expected.

Manufacturer Narrative

Describe event or problem: additional information.Correction to brand name, common device name, and model/lot #.Correction to recall: approximate age of device: 6 months correction the device was not returned for evaluation.A correlation between the device and the reported event could not be conclusively determined.The patient and family information for the centrimag ventricular assist system (vas) lists stroke, major bleeding, kidney failure and heart failure as potential adverse events that may be associated with the use of the centrimag 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.

Event Description

Additional information: the original report of the manufacturer's cannula involved in the event of 12/11/2013 was incorrect.Information provided by the vad coordinator indicated that the cannula involved in the event was another manufacturer's device.

• Brand Name: THORATEC CENTRIMAG
• Type of Device: CENTRIMAG BLOOD PUMP
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• 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: 5749305
• MDR Text Key: 48188101
• Report Number: 2916596-2016-01182
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 102953
• Device Lot Number: 102983
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Weight: 81