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

Model Number	106522
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tunneling adaptor was dropped while trying to connect to the pump cable during pump preparation and the apical cuff was unable to connect to the pump.The backup adaptor and cuff were used instead of the original kit.The patient was recovering in the intensive care unit.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported engagement issue could not be confirmed through this evaluation as apical cuff, lot number 8081321, was not returned for evaluation.A specific cause for this event could not conclusively be determined.The relevant sections of the device history records for (b)(6) were reviewed, including the cuff lock installation and inspection, and showed no deviations from manufacturing or quality assurance specifications.Review of the lvad (left ventricular assist device) final assembly device history records showed that the cuff lock installed on (b)(6)passed all inspection and testing steps.Heartmate 3 (hm3) left ventricular assist system (lvas) instructions for use (ifu) is currently available.The ifu provides instructions on all surgical procedures, including preparing the ventricular apex site and inserting the pump in the ventricle.The ifu 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 (left ventricular assist device).If the slide lock mechanism on the hm3 lvad fails to engage, do not make further attempts to engage until retracting the slide lock mechanism.Evidence of slide lock mechanism failing to engage will be either visual evidence of the yellow ¿wings¿ or a tactile feel of three ridges versus one.The slide lock will not engage the apical cuff unless initially fully retracted.If difficulty persists when engaging the slide lock mechanism, the lvad should be removed from the apical cuff to visualize what might be preventing the connection.The suture knots should not interfere with the connection.If a sealing agent is used on or near the apical cuff, it should not interfere with the slide lock mechanism.The surgical procedures section also includes information on de-airing the pump.During the implant process, a complete backup system (implant kit and external components) must be available on-site and in close proximity for use in an emergency.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: 13524152
• Report Number: 2916596-2022-00658
• Device Sequence Number: 5299048
• Product Code: DSQ
• UDI-Device Identifier: 00813024012825
• UDI-Public: 00813024012825
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2022

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 Expiration Date: 09/11/2024
• Device Model Number: 106522
• Device Catalogue Number: 106522US
• Device Lot Number: 8081321
• 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: 01/28/2022
• Supplement Date Received by Manufacturer: 04/12/2022; 05/03/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 04/14/2022; 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2021
• 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 Sex: Unknown