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

Model Number 106524US

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/29/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation conclusion.The evaluation of heartmate 3 left ventricular assist system (lvas), serial number (b)(4), confirmed damage to the locking arms of the cuff lock.The observed damage to the cuff lock appeared to have prevented the o-ring and mini cuff from sealing properly when the pump was engaged, which would have contributed to the reported blood leak.The evaluation was unable to determine when or how the cuff lock arms became bent out of specification.The pump was returned assembled with the cuff lock in the unlocked position.The apical cuff was not returned.The cuff lock moved freely upon manipulation and could not be forced into the locked position without an apical cuff in place, as intended by design.The o-ring that seals the interface between the inflow cannula and the mini apical cuff was present and appeared to be free of damage or defect.Measurements were taken of the cuff lock and confirmed that both locking arms were bent out of specification.Review of manufacturing documentation, which includes functional testing and visual inspection of the cuff lock for bent arms, found no deviations in manufacturing or quality assurance specifications.The cuff lock assembly was reassembled, and test apical cuff and mini apical cuffs were connected.The cuff lock engaged easily without issue.The evaluation was unable to determined when or how the cuff lock arms became bent.The remainder of the device appeared unremarkable.Examination of the blood-contacting surfaces found no depositions or defects.The heartmate 3 left ventricular assist system (lvas) instruction for use (ifu), rev.C, is currently available.¿surgical procedures¿, contains information including preparing the ventricular apex site and inserting the pump in the ventricle.This section cautions that after the apical cuff has been sewn to the heart, the metal ring on the apical cuff should extend above the felt surface to allow proper engagement and locking with the slide lock of the heartmate 3 left ventricular assist device (lvad).If the slide lock mechanism on the heartmate 3 lvad fails to engage, do not make further attempts to engage until retracting the slide lock mechanism.Evidence of slide lock mechanism failing to engage will be either visual evidence of the yellow ¿wings¿ or a tactile feel of three ridges versus one.The slide lock will not engage the apical cuff unless initially fully retracted.If difficulty persists when engaging the slide lock mechanism, the lvad should be removed from the apical cuff to visualize what might be preventing the connection.If a sealing agent is used on or near the apical cuff, it should not interfere with the slide lock mechanism.During the implant process, a complete backup system (implant kit and external components) must be available on-site and in close proximity for use in an emergency.The relevant sections of the device history records for (b)(4) were reviewed, including the cuff lock installation and inspection, and showed no deviations from manufacturing or quality assurance specifications.The lvas kit was shipped on 22feb2022.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the heartmate 3 device was implanted via left thoracotomy and hemi-sternotomy.Hemostasis was not attained when the pump was locked into the mini apical cuff.Blood was leaking between the inflow cannula and the apical cuff.The surgeon attempted to reseat the pump 3 times at a flat angle and rotate the pump once locked in place.No bleeding was present at the suture line as the mini cuff apical holder was used to ensure hemostasis at the suture line.The thoracotomy approach was abandoned and a fill midline sternotomy was performed.Bleeding persisted in the same location after reseating the pump twice into the sewing ring.A second pump was opened, primed, and used.The original apical cuff was left in place due to concern for damaging the patient's myocardium.The second pump locked into place with trace amount of bleeding noted.Hemostasis was eventually attained.The patient remained hospitalized but was stable.

Manufacturer Narrative

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 (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: 14472451
• MDR Text Key: 292395902
• Report Number: 2916596-2022-10790
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8330822
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• 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; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Hispanic
• Patient Race: White