MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE; VENTRICULAR (ASSIST) BYPASS

Model Number 106523

Device Problems Disconnection (1171); Electromagnetic Interference (1194); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2021

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that one event had electromagnetic interference between the multifunctional electrocardiograph and heartmate 3.The problem was not solved by keeping the electrocardiograph cable arrangement as far away from the pump as possible.It was reported that one event had electromagnetic interference during the implantation surgery between combined medical device and the heartmate 3.The problem was resolved by keeping the cable arrangement as far away from the pump as possible.It was reported that 8 events had electromagnetic interference between multi-item monitor and heartmate 3.It was reported that one event had temporary electromagnetic interference between a defibrillator and heartmate 3 after pump implant procedure.It was reported that during one event after treatment for massive bleeding, a chest x-ray revealed that the bend relief had come off, so the chest was reopened, and the bend relief was reconnected to the base of the blood feeding graft and closed.There was a clear association between the disengagement of the bend relief and this product.

Manufacturer Narrative

This is one of the original reports submitted for the historical jmacs patient registry review in japan through mcs abbott japan affiliate.Individual reports have been submitted under the corresponding mfr#'s and linked back to this mfr# 2916596-2022-01917.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• 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 ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14084303
• MDR Text Key: 289096053
• Report Number: 2916596-2022-01917
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: 00813024011286
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106523
• Device Catalogue Number: 106762
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 04/12/2022
• Supplement Dates Manufacturer Received: 09/29/2022
• Supplement Dates FDA Received: 09/30/2022
• 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: Initial
• Patient Sequence Number: 1