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

Model Number 106524

Device Problems Break (1069); Mechanical Problem (1384); Pumping Stopped (1503)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

The heartmate 3 lvas was implanted during the (b)(6) clinical trial, ide# (b)(4).Fda approval for heartmate 3 lvas was received on 23 august 2017.The trial is locked.The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4).No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that the patient's driveline was completely severed between exit site and modular connection.Patient stated the cut occurred during a dressing change.Patient went to emergency department and was admitted to hospital.On (b)(6) 2020, manufacturer representative arrived onsite for heartmate 3 driveline evaluation/repair.Found driveline completely severed approximately 2 inches from the exit site.Heartmate 3 perc cable replacement performed.Spliced patient's original severed driveline cable sn# (b)(4) without issue.Unable to tie strength member string due to 2 inch driveline cable length from the exit site.Pump powered on without issue.Post repair there were no issues noted.

Manufacturer Narrative

Manufacturer¿s investigation conclusion: the report of a severed pump cable was confirmed through the evaluation of the submitted images, as well as through an observation by an onsite abbott representative.An onsite driveline repair was performed on (b)(6) 2020 by abbott personnel.The driveline had been severed approximately 2 inches from the exit site.The distal portion of the driveline wires was replaced without issue; however, the strength member string was unable to be tied together due to its proximity to the exit site.No issues were noted post-repair.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The relevant sections of the device history records for the percutaneous lead were also reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped to the customer on 04nov2016.The heartmate 3 left ventricular assist system (hm3 lvas) instructions for use (ifu), rev.C, is currently available.Section 5 of this document cautions that sharp bends, twists, or kinks in the driveline may make it more susceptible to wear and fatigue over time.Section 6 of this document cautions the user to avoid pulling on or moving the driveline.This section emphasizes not to twist, kink, or sharply bend the driveline, system controller power cables, or mobile power unit patient cable, which may cause damage to the wires inside, even if the external damage is not visible.Damage to the driveline or cables could cause the pump to stop.If the driveline or cables become twisted, kinked, or bent, carefully unravel and straighten.Section 7 of this ifu also provides instruction regarding the driveline in a sub-section entitled "what not to do: driveline and cables".Section 8 of this ifu provides additional information regarding the driveline via ¿care of the driveline¿.The hm3 lvas patient handbook (rev.C) is also currently available.The patient handbook also provides information on proper care of the driveline.Section 8 of the patient handbook provides information regarding handling emergencies.The user should check the driveline daily for signs of damage (cuts, holes, tears) and call their hospital contact right away if the driveline is damaged (or might be damaged).No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11149909
• MDR Text Key: 228405418
• Report Number: 2916596-2020-06371
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Model Number: 106524
• Device Catalogue Number: 106524US
• Device Lot Number: 5718483
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Weight: 100