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

Model Number 106524US

Device Problems Mechanical Problem (1384); Obstruction of Flow (2423)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 08/09/2021

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 reported that the patient had an outflow graft obstruction that required frequent monitoring of the patient's condition.The obstruction was confirmed via computed tomography angiography (cta).The outflow graft showed a significant amount of thrombosis proximally.The shape of the thrombus both cysts in somewhat amorphic; however, overall luminal narrowing was approximately (b)(6) at its maximum.Thrombus was seen in the proximal 8 cm of the graft.

Manufacturer Narrative

Section d9: correction; the pump was returned under manufacturer report number 2916596-2021-06606.Manufacturer's investigation conclusion: the report of outflow graft thrombosis could not be confirmed through this evaluation as no photos or images were submitted.The pump was returned under manufacturer report number 2916596-2021-06606; refer to this investigation for pump evaluation.It was reported that the outflow graft showed a significant amount of thrombosis in the proximal 8 centimeters of the graft.The shape of the thrombus was noted as cystic and somewhat amorphic.Overall luminal narrowing of the thrombus was approximately 65-70% at its maximum.The patient remained ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6), until undergoing heart transplantation on (b)(6) 2021 due to outflow graft occlusion (manufacturer report number 2916596-2021-06606).The heartmate 3 left ventricular assist system (lvas) instruction for use (ifu), rev.C, is currently available.Section 1 of this document entitled ¿introduction¿ lists pump thrombosis as an adverse event that may be associated with the use of the heartmate 3 lvas.Section 5 of the ifu, "surgical procedures", contains information on "preparing the sealed outflow graft" and explains that prior to implantation, the bend relief should be disengaged from the graft for the de-airing procedure.Section 5 also contains a sub-section on "attaching the sealed outflow graft to the aorta", which instructs the user to stretch the graft completely and then measure and cut the sealed outflow graft to the appropriate length.Section 5, under "attaching the sealed outflow graft to the pump", instructs the user to verify that the outflow graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight.Section 5, under "de-airing the pump", cautions the user: "do not rotate/twist the sealed graft.Check the alignment of the black line on the graft to verify that the sealed graft is not twisted or kinked." this section also explains how to attach the bend relief once the vent needle has been removed from the sealed outflow graft and leaks have been ruled out.Section 1 lists the outflow graft clip as a required component for implant.Section 5, further instructs the user to ¿attach the outflow graft clip to prevent post-operative outflow graft twisting¿ and warns that failure to install the outflow graft clip so that it is flush with the bend relief can allow graft twisting or abrasion which may lead to serious adverse events such as bleeding, graft occlusion, thrombosis, and/or death.Section 6 entitled ¿patient care and management¿ lists thromboembolism as a potential late postimplant complication and provides information regarding anticoagulation, including recommended international normalized ratio (inr) values.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specification.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
• 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: 12924479
• MDR Text Key: 284697110
• Report Number: 2916596-2021-06791
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/11/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7034374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 02/07/2022
• Supplement Dates FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2019
• 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): Hospitalization
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White