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

Model Number	106522INT
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	03/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Heartmate 3 lvas implant kit ((b)(4)).No further information was provided.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that there was bleeding after the pump was locked into the apical cuff.The source of bleeding was between the apical cuff and the pump.The bleeding resolved after disengaging the pump from apical cuff 3 times.Related manufacturer report number 2916596-2021-01348.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the report of bleeding from apical cuff site could not be confirmed and a specific cause for the reported event could not be determined through this evaluation.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 assembly device history records showed that the cuff lock installed on (b)(6) passed all inspection and testing.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 (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11465542
• Report Number: 2916596-2021-01347
• Device Sequence Number: 19732220
• Product Code: DSQ
• UDI-Device Identifier: 05415067030801
• UDI-Public: 05415067030801
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2021

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: 11/12/2022
• Device Model Number: 106522INT
• Device Catalogue Number: 106522US
• Device Lot Number: 7663558
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 04/06/2021; 04/15/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/12/2021; 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization