MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS MINI APICAL CUFF KIT

Model Number	10005877
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Approximate age of device: 0 days (never implanted).The device was returned for investigation.The evaluation is not yet complete.The patient remains ongoing with the device.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.
Event or Problem Description
The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2019.It was reported that the account was unable to lock the heartmate 3 pump onto the mini apical cuff.The account did not see any sutures blocking the mechanism nor was any glue used.The account attempted to lock the pump onto the apical cuff on the back table, the locking mechanism worked fine.The account decided to replace the mini apical cuff with a standard apical cuff.The device was sent back for evaluation.

• Brand Name: HEARTMATE 3 LVAS MINI APICAL CUFF KIT
• Common Device Name: HEARTMATE 3 LVAS MINI APICAL CUFF KIT
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 8320938
• Report Number: 2916596-2019-00552
• Device Sequence Number: 19175197
• Product Code: DSQ
• UDI-Device Identifier: 00813024013082
• UDI-Public: 00813024013082
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

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: 10/31/2021
• Device Model Number: 10005877
• Device Catalogue Number: 10005877
• Device Lot Number: 6712679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 04/23/2019
• 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; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 52