MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524US

Device Problem Malposition of Device (2616)

Patient Problems Tachycardia (2095); Ventricular Fibrillation (2130)

Event Date 03/09/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient had multiple episodes of orthostatic hypotension.The patient also had an episode of ventricular tachycardia with multiple shocks delivered on (b)(6) 2021.The patient now has incessant vt which was suspected to be due to pump inflow mispositioning.A vt ablation was scheduled for (b)(6) 2021.The patient was noted to be stable on lidocaine drip.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6) , and the reported cardiac arrhythmia could not be conclusively established through this evaluation.Additionally, the reported pump inflow malposition could not be conclusively established through this evaluation as no images were submitted.It was reported that the patient had multiple episodes of orthostatic hypotension.Additionally, the patient had an episode of ventricular tachycardia with multiple shocks delivered on (b)(6) 2021.The patient had incessant ventricular tachycardia which was reportedly suspected to be due to pump inflow mispositioning.A ventricular tachycardia ablation was scheduled for (b)(6) 2021.Multiple attempts for additional information regarding the reported events were sent to the account.However, no additional information was provided.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).The relevant sections of the device history records (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 lvas ifu and the heartmate 3 lvas patient handbook are currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events, including cardiac arrhythmia, that may be associated with the use of the heartmate 3 left ventricular assist system.Section 5 "surgical procedures" explains how to insert the pump in the ventricle and instructs the user to take care to avoid orienting the inlet towards the interventricular septum as pump function will be compromised in the presence of inlet obstruction.The steps to adjust the orientation of the pump are also outlined in this section.Section 6 of the ifu, ¿patient care and management¿, also lists arrhythmia as a potential late postimplant complication.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11577432
• MDR Text Key: 243924616
• Report Number: 2916596-2021-01380
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7760412
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 115