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

Catalog Number 106015

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Blood Loss (2597)

Event Date 08/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Approximate age of device - 1 day.The patient remains on lvad support with no further issues reported.No additional 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).It was reported that following lvad implant, the patient experienced bleeding, and returned to the operating room for chest exploration and washout.During the procedure, the lvad inflow cannula became temporarily dislodged from the sewing ring and had to be reinserted.The cannula was secured with a combination of a suture, plastic ties, and sternal wire.There were no reported patient issues associated with the inflow cannula becoming dislodged temporarily.It was reported that once hemostasis was achieved, the hemodynamics were excellent, with good right ventricular function and a "well-functioning lvad." no additional information was reported.

Manufacturer Narrative

No product was returned for evaluation.The reported blood leak due to the pump becoming dislodged from the apical sewing ring could not be confirmed.Bleeding 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 the device met applicable specifications.No further information was provided.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: 6339710
• MDR Text Key: 67701224
• Report Number: 2916596-2017-00344
• 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
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

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: Health Professional
• Device Expiration Date: 01/31/2019
• 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: 01/24/2017
• Initial Date FDA Received: 02/17/2017
• Supplement Dates Manufacturer Received: 10/17/2017
• Supplement Dates FDA Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2016
• 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): Required Intervention
• Patient Age: 68 YR