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

Model Number	106522
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	05/26/2020
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
Related manufacturer's report number: 2916596-2020-02869.It was reported that during the implant, there was bleeding noted to be coming from between the apical cuff and pump attachment.It was attempted to slightly turn the pump.It ended up unlocking the cuff lock, pushing down on the pump, giving a slight rotation, and re-engaging the cuff lock.The bleeding stopped.
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 determined through this evaluation.It was reported that during the implantation of (b)(6) on (b)(6) 2020, bleeding was noted to be coming from in between the apical cuff and pump attachment.The implanting surgeon attempted to slightly turn the pump, but the bleeding continued.The surgeon ultimately unlocked the cuff lock, pushed down on the pump, gave a slight rotation, and re-engaged the cuff lock.Upon re-engaging the cuff lock, the bleeding reportedly stopped.The patient remains ongoing on (b)(6) with no further related issues.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.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 implant kit was shipped on (b)(6) 2020.The heartmate 3 lvas ifu lists bleeding as an adverse event that may be associated with the use of the heartmate 3 lvas.This document also contains information regarding the preparation of the ventricular apex site, including how to affix the apical cuff to the left ventricle.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.

• Brand Name: HEARTMATE 3 APICAL CUFF
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10140772
• Report Number: 2916596-2020-02870
• Device Sequence Number: 3637055
• Product Code: DSQ
• UDI-Device Identifier: 00813024012825
• UDI-Public: 00813024012825
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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: 03/12/2022
• Device Model Number: 106522
• Device Lot Number: 7254111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 08/29/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEARTMATE 3 LVAS IMPLANT KIT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Weight: 111