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

Model Number	10005877
Medical Device Problem Codes	Fluid/Blood Leak (1250); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.Section e1: reporter address line 1: (b)(6).
Event or Problem Description
It was reported that during implant the mini apical cuff was used and while anchoring the heartmate 3 pump to the ring, a double click was heard and no yellow bars in the purple metal part showed.There was bleeding between the pump and the cuff.The pump was taken off the cuff and the apical cuff holder was used to test hemostasia in the ring.Any point of blood was observed during the test so the mini apical cuff was well attached.When the pump was anchored to the cuff it started to bleed again.The pump was started to see if any air was entering between the pump and the cuff.There was no air entering.Everything was disconnected and the pump was relocated.It was then noticed that while pressing the pump to the cuff there was no bleeding but when the pump was free in the chest the bleeding restarted.The pump was taken off the cuff again and tried with the apical cuff from the heartmate 3 kit.When the apical cuff was anchored it was discovered that the cuff could move without restriction, so it was concluded that the problem was anchoring the pump to the cuff and backup heartmate 3 kit was opened.No bleeding occurred on the new pump.Reference regulatory report mfr # 2916596-2024-01653.
Additional Manufacturer Narrative
Section d4: catalog number corrected section d5: operator of device corrected manufacturer¿s investigation conclusion: the specific cause of the reported bleeding and ease of pump rotation could not be confirmed through this evaluation.The issue reportedly resolved when the backup pump was implanted.The mini apical cuff remains in use.(b)(6) was evaluated under mfr # 2916596-2024-01653 and addresses the reported blood leak from the pump-cuff connection.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.Heartmate 3 mini apical cuff kit instructions for use (ifu), rev.E, is currently available.The section entitled ¿surgical procedures¿ explains how to prepare the mini apical cuff and the apical cuff holder for use.Section ¿directions for use¿ explains how to secure the mini apical cuff to the ventricle.This section also instructs the user that the mini apical cuff should be affixed only by the sew-then-cut method and pledgets should be placed no more than one and a half centimeters from the edge of the felt.Affixing the mini apical cuff using methods other than the prescribed technique can lead to challenges engaging the slide lock mechanism.The heartmate 3 left ventricular assist system (lvas) ifu rev.G, is currently available.No specific device-related issues or adverse events were reported; however, the heartmate 3 lvas ifu provides a list of adverse events that may be associated with the use of the heartmate 3 left ventricular assist system in section 1, ¿introduction¿.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS MINI APICAL CUFF KIT
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18925058
• Report Number: 2916596-2024-01654
• Device Sequence Number: 4540454
• Product Code: DSQ
• UDI-Device Identifier: 00813024013082
• UDI-Public: 00813024013082
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10005877
• Device Catalogue Number: 10005877
• Device Lot Number: 10014245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2023
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 79 KG