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

Model Number 106015

Device Problems Mechanical Problem (1384); Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Lactate Dehydrogenase Increased (4567)

Event Date 10/15/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was requested that log files be urgently read for concerns related to pump thrombus.The patient was seen in the clinic on (b)(6) 2021 after local lab reported elevated ldh (lactate dehydrogenase).There were no power spikes or elevated flows.Blood work and urine analysis is pending.The log file captured routine events; the vad (ventricular assist device) and peripheral equipment appeared to be functioning as intended.The patient's baseline ldh was around 500-700 and was 807 on (b)(6) 2021.The patient was treated with 325 mg (b)(6), 75 mg (b)(6), and (b)(6) with an inr goal on 2.5-3.

Event Description

Pump thrombus was not confirmed, no additional workup was done.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the device and the reported elevated lactate dehydrogenase (ldh) could not be conclusively established through this evaluation.A specific cause for this event could also not be determined.The submitted log file contained data from 23sep2021 to 15oct2021.The file appeared to show the system operating as intended.The patient remains ongoing on heartmate ii (hmii) left ventricular assist system (lvas), serial number (b)(6).No further related events have been reported at this time.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 "introduction¿ lists the adverse events that may be associated with use of the heartmate ii left ventricular assist system, including hemolysis.Section 6 entitled "patient care and management" provides information on anticoagulation, including recommended international normalized ratio (inr) values.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 (ASSISST) 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: 12807388
• MDR Text Key: 284361490
• Report Number: 2916596-2021-06414
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/10/2021
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 7452441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• 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
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 93 KG