MAUDE Adverse Event Report: ABBOTT ABBOTT; HEARTMATE II LVAS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 12/18/2019

Event Type  Death  

Event Description

Vad coordinator notified 12/17/2019 that pt would be transitioning to hospice care from spinal rehab center in (b)(6).Vad coordinator received phone call 12/18/2019 that pt had expired and given instructions to turn off lvad.No further info received from (b)(6) facility.

• Brand Name: ABBOTT
• Type of Device: HEARTMATE II LVAS
• Manufacturer (Section D): ABBOTT; 6300 bee cave rd; austin TX 78746
• MDR Report Key: 9558458
• MDR Text Key: 174101994
• Report Number: 9558458
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/23/2019

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2019
• Distributor Facility Aware Date: 12/18/2019
• Device Age: 2 YR
• Event Location: Other
• Date Report to Manufacturer: 12/23/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Weight: 119