MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 APICAL CUFF; VENTRICULAR (ASSIST) BYPASS

Model Number	106522
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the patient experienced persistent bleeding between the metal at the cuff post-op.The heartmate 3 was initially engaged with the apical cuff then the cuff was removed with unlocking tool after difficulty getting the tool to disengage the locking mechanism.The implant approach was via intercostal, bilateral thoracotomy.The pump engaged again but the patient continued to bleed around the pump.This is thought to be due to poor engagement between the pump/cuff.Additional information: the pump was not replaced and the bleeding resolved after umbilical tape was used around inflow cannula to secure the pump and apical cuff engagement and resolve bleeding.The patient is stable.
Event or Problem Description
Related manufacturer report number: 2916596-2020-03811.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: a specific cause for the report of a blood leak between the apical cuff and the pump during implant could not be conclusively determined through this evaluation.It was reported that the patient experienced persistent bleeding between the metal at the cuff during implantation on (b)(6) 2020.The heartmate 3 pump was initially engaged with the apical cuff without difficulty and then was removed with the unlocking tool after difficulty getting the tool to disengage the locking mechanism.The pump was engaged again a second time, however the patient continued to have bleeding around the pump, thought to be due to poor engagement between the pump and the apical cuff.Per additional information from the account, the patient is stable.The bleeding between the apical cuff and the pump resolved after umbilical tape was used on the area where the apical cuff and inflow cannula meet.The patient is ongoing on heartmate 3 left ventricular assist system, serial number (b)(6).The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.Additionally, review of the lvad final assembly device history records showed that the cuff lock installed on (b)(6) passed all inspection and testing steps.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), is currently available.Section 1 ¿introduction¿ of this document lists bleeding as an adverse event that may be associated with the use of the heartmate 3 lvas.Section 5 ¿surgical procedures¿ (under ¿preparing the ventricular apex site¿) contains information regarding the preparation of the ventricular apex site, including how to affix the apical cuff to the left 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 lvad.Ensure that apposition between the myocardial tissue and the cuff felt is continuous and sufficiently forceful to prevent bleeding.No further information was provided.The manufacturer is closing the file on this event.
Additional Manufacturer Narrative
No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 APICAL CUFF
• Common Device Name: 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: 10372525
• Report Number: 2916596-2020-03820
• Device Sequence Number: 3619400
• Product Code: DSQ
• UDI-Device Identifier: 05415067030801
• UDI-Public: 05415067030801
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2022
• Device Model Number: 106522
• Device Catalogue Number: 106522US
• Device Lot Number: 7331901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 03/29/2021; 05/03/2022
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 03/30/2021; 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LVAS KIT, HM3; LVAS KIT, HM3
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 77 KG