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

Catalog Number 106015

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Death (1802); Heart Failure (2206)

Event Date 11/26/2014

Event Type  Death  

Event Description

The patient was implanted with a left ventricular assist device (lvad).It was reported that the patient was admitted due to suspected worsened heart failure possibly related to right heart failure.As part of the patient¿s routine care, the hospital team performed an echocardiogram and found that the inflow conduit was malpositioned and was ¿sucking¿ in the interventricular septum.The patient¿s heart failure symptoms worsened and a cardiac catheterization procedure was performed that showed right and left heart failure.It was determined that an attempt to reposition the inflow conduit was required.It was reported that during the operative procedure, the inflow conduit unexpectedly dislodged from the heart.The patient's aortic valve had previously been oversewn.The disconnection and cardiopulmonary resuscitation (cpr) lasted approximately 8 minutes.The patient¿s family chose to withdraw care due to grave concern for the patient¿s neurological status.No additional information was made available.

Event Description

A user facility report was received from the (b)(4) registry stating: "echocardiogram showed marked ventricular assist device inflow cannula obstruction, ct scan showed marked anterior angulation of inflow cannula and cardiac catheterization showed elevated pcwp.Pt taken to or.Repositioning of cannula was done.In preparing to close incision the device cannula came out of the lv apex with laceration of the lv in the process.Pt went into cardiac arrest and placed on cardiopulmonary bypass and perfusion restored.Family requested no further measures taken.Pt removed from cardiopulmonary bypass and expired.".

Manufacturer Narrative

Pt weight - not available.Approximate age of device - 48 days device evaluated by manufacturer - the device is expected to be returned but has not been received.Placeholder.

Manufacturer Narrative

(b)(4).No further information is available at this time.A supplemental report will be submitted when the manufacturer's investigation is completed.

• 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: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 781272-013
• MDR Report Key: 4367888
• MDR Text Key: 5236790
• Report Number: 2916596-2014-02321
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2014

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: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 106015
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2015
• Initial Date FDA Received: 12/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/23/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 YR