MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

Catalog Number 106015

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2017

Event Type  Injury  

Manufacturer Narrative

Approximate age of device- 39 days (calculated from date of manufacture).Manufacturer's investigation conclusion: the report of an irregularly shaped white washer can be confirmed.The pump was returned with the driveline intact and the outflow elbow properly attached.Examination of the distal side of the outflow elbow revealed the reported irregularly shaped white washer.A specific cause for the warping of the washer cannot be conclusively determined.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

It was reported that while the or team was preparing the heartmate ii device for implant, they noted an irregular shape to the white o ring on the outflow elbow.The team decided not to use this pump and implanted a different pump instead.There was no adverse event to the patient due to the delay of device preparation.No additional information was provided.

Manufacturer Narrative

Investigation summary: the report of an irregularly shaped white washer can be confirmed.During implant, the or team noted an irregular shape to the white washer of the outflow elbow.A photo of the washer was submitted.The team did not feel comfortable using this pump, so they obtained another implant kit and successfully implanted the patient.The pump was returned with the driveline intact and the outflow elbow properly attached.Examination of the distal side of the outflow elbow revealed the reported irregularly shaped white washer.A specific cause for the warping of the washer cannot be conclusively determined.The heartmate ii lvas ifu provides detailed instructions for pump preparation prior to implant and states to examine the outflow elbow of the pump to verify the presence of a white washer.If the white washer is missing or damaged, do not use the pump.Obtain another device before continuing.Furthermore, the ifu warns that "during the implant process, a complete backup system (implant kit and external components) must be available on-site and in close proximity for use in an emergency.No further information was provided.The manufacturer is closing the file for the event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 8114260
• MDR Text Key: 128720214
• Report Number: 2916596-2018-05338
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 106015
• Device Lot Number: 5967986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 72