MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSIST) BYPASS

Model Number 106015

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Fatigue (1849); Muscle Weakness (1967); Ventricular Fibrillation (2130); Dizziness (2194)

Event Date 07/01/2022

Event Type  malfunction  

Manufacturer Narrative

Related mfrs: # 2916596-2022-12289; 2916596-2019-03777.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient in the past had right ventricular dysfunction and weight gain.The patient had a driveline fault alarm but no evidence of progression.The driveline fault alarm was likely due to short-to-shield internal damage to the driveline after significant weight gain.On (b)(6) 2022 patient began experiencing dizziness after a 1 mile walk/run and felt overheated.The patient held lasix and reported improvement in symptoms on (b)(6) 2022.On (b)(6) 2022 the patient took one dose of lasix.The patient called the office on (b)(6) 2022 with concern of worsening dizziness, weakness, fatigue, and dyspnea with exertion.At this time patient's flow were noted to be 3.5-4.0 liters per minute (lpm) which was much reduced from baseline of 5-6 lpm.The patient's pulsatility index was also low, 1.5-2.5.Lasix and lisinopril were held and patient was encouraged to hydrate and come into office but patient was unable to because they did not have a ride.On (b)(6) 2022 patient presented to clinic and was found to be in sustained ventricular fibrillation.The patient had no history of arrhythmia.The patient was taken to emergency department and had direct current cardioversion twice with successful conversion to normal sinus rhythm.Log files captured known driveline fault alarms and otherwise only routine events.The flow averaged 4.1 lpm in the log file and no period of flow drop from 5-6 to 3-4 lpm was confirmed.

Manufacturer Narrative

Manufacturer's investigation conclusion: analysis of the submitted log file confirmed driveline fault alarms.Based on past experience with the heartmate ii left ventricular assist system (hmii lvas) and similar reported events, these events could be indicative of an issue with the driveline; however, a direct correlation between these findings and hmii lvas, serial number (b)(6) could not be conclusively established through this evaluation.The account submitted log files for review.122 yellow wrench advisories associated with 122 driveline faults were captured throughout the log file which were silenced.These driveline faults appeared to result from an issue with phase 3.The other phases did not appear to contribute to the fault.Based on previous complaint experience, the captured events appear consistent with a potential driveline wire compromise.The patient remains ongoing on heartmate ii lvas, serial number (b)(6).The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.Review of the device history records for driveline serial number (b)(6) found no deviations from manufacturing or quality assurance specifications.The heartmate ii lvas instruction for use (ifu) is currently available.This ifu lists cardiac arrhythmia as an adverse event that may be associated with the use of the heartmate ii left ventricular assist system.Section 1 of this ifu contains information regarding definitions and usage of pump speed, power, flow, and pulsatility index (pi).Additionally, section 6 of this document explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.The section "system operations" describes the "driveline" and outlines indications of driveline damage as well as how to respond to such events.The section "equipment storage and care" describes "care of the driveline." the section "alarms and troubleshooting" outlines alarms and how to respond to them, including low-speed events and driveline faults.The heartmate ii lvas patient handbook is currently available.Section 4 of this handbook contains a section on ¿caring for the driveline;" however, all heartmate ii lvad drivelines have the potential for wire/shield breakdown to occur dependent upon length of use and movement/flexing over time.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• 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: 15124560
• MDR Text Key: 304606506
• Report Number: 2916596-2022-12271
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2015
• 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): Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 139 KG