MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T); BIVENTRICULAR REPLACEMENT DEVICE

Model Number 500101-001

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

Patient Problem Stroke/CVA (1770)

Event Date 07/28/2021

Event Type  Injury  

Manufacturer Narrative

Syncardia systems freedom driver system guidebook for patients and caregivers - us (f-900014-en rev 006) section 10 additional information: 10.2.8 reasons for not smoking or using tobacco products - smoking and the use of tobacco products can cause the blood vessels in your body to constrict or tighten.This can lead to elevation in blood pressure and can decrease the amount of oxygen rich blood that reached the tissues in your body.Smoking and the use of tobacco products is prohibited.If you have difficulty with smoking cessation, consult your doctor for help.Caution box do not smoke.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.(b)(4) initial.

Event Description

The customer, a syncardia certified hospital, reported that the patient was admitted for an urgent embolectomy.Additional information was requested and the following was provided: "patient has been depressed and is smoking 1-2 packs of cigarettes a day.When he went to bed at 6 am on (b)(6) 2021, he had right side weakness and was brought to the er by ambulance.He had an embolectomy and is 100% recovered as of (b)(6) 2021.This is the second stroke this year while on coumadin.The freedom driver supporting the patient at the time of the event did not alarm or show any sign of malfunction.The patient was discharged home supported by a freedom driver on (b)(6) 2021".

• Brand Name: SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: don webber ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 12355683
• MDR Text Key: 267741587
• Report Number: 3003761017-2021-00159
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/19/2021

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: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 110942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 30 YR