MAUDE Adverse Event Report: ABBOTT/THORATEC CORP. HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE; VENTRICULAR (ASSIST) BYPASS

Device Problems Improper Flow or Infusion (2954); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

I was implanted with the heartmate 3 on (b)(6) 2015 and starting on (b)(6) 2020 i starting getting persistent low flow alarms from the device.On (b)(6) 2020 i went to see my lvad team and they ordered a ct scan of the chest with contrast.The test revealed an eccentric spiraling ¿nonenhancing¿ in the outflow graft, concerning for the graft twist.At that point i was admitted to the hospital and was subject to more test.I am currently still in the hospital as they determine their course of action.Fda safety report id # (b)(4).

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): ABBOTT/THORATEC CORP.
• MDR Report Key: 9706224
• MDR Text Key: 179429659
• Report Number: MW5092959
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 88