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

Model Number	106522
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	08/25/2020
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 when the original apical cuff was implanted, the suture line was bleeding and could not be controlled.The surgeon made the decision to remove the cuff and start again with a fresh apical cuff.The additional cuff was opened and the new serial number was placed on the patient¿s documentation in place of the original cuff stickers.
Additional Manufacturer Narrative
Section d4 (model number): correction.Section d4, h4: additional information.Manufacturer's investigation conclusion: the report of bleeding from the suture line of the heartmate 3 apical cuff could not be confirmed and a specific cause for the reported event could not be determined through this evaluation.The device history record was reviewed and showed no deviations from manufacturing or quality assurance specifications.(b)(6), was shipped with apical cuff part number 10001258, lot number 7392365.The implant kit was shipped on (b)(6), 2020.The heartmate 3 lvas instructions for use (ifu) lists bleeding as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.In addition, the ifu provides instructions on securing the apical cuff to the left ventricle and includes information regarding the suturing method.The ifu instructs to target the placement of the sutures on the black circumferential line marked on the apical cuff, which will help ensure that a hemostatic connection between the apical cuff and the heart tissue, for which uninterrupted opposition between the myocardial tissue and the apical cuff felt is required.In addition, this document cautions to 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: 10528109
• Report Number: 2916596-2020-04501
• Device Sequence Number: 3118397
• Product Code: DSQ
• UDI-Device Identifier: 05415067030801
• UDI-Public: 05415067030801
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2023
• Device Model Number: 106522
• Device Catalogue Number: 106522US
• Device Lot Number: 7392365
• 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: 08/28/2020
• Supplement Date Received by Manufacturer: 12/18/2020; 05/03/2022
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 12/21/2020; 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 173 KG
• Patient Ethnicity: Non Hispanic