MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH-T; BIVENTRICULAR REPLACEMENT DEVICE

Model Number 500101-001

Device Problems Restricted Flow rate (1248); Mechanical Problem (1384)

Patient Problems Complaint, Ill-Defined (2331); Low Cardiac Output (2501)

Event Date 12/19/2017

Event Type  Injury  

Manufacturer Narrative

The explanted tah-t has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.

Event Description

The customer, a syncardia certified hospital, reported that the patient's condition deteriorated overnight with decreasing flows on the right and left ventricles and increasing difficulty in full ejection on the right ventricle.The customer also reported that the patient is suspected to have a lung issue with tamponade.The customer also reported that both ventricles of the tah-t were replaced.The customer also reported that after the right ventricle was removed it appeared to the customer that the outflow valve did not move smoothly.

Event Description

The customer, a syncardia certified hospital, reported that the patient's condition deteriorated overnight with decreasing flows on the right and left ventricles and increasing difficulty in full ejection on the right ventricle.The customer also reported that the patient is suspected to have a lung issue with tamponade.The customer also reported that both ventricles of the tah-t were replaced.The customer also reported that after the right ventricle was removed it appeared to the customer that the outflow valve did not move smoothly.

Manufacturer Narrative

The explanted tah-t was returned to syncardia for evaluation.An explant analysis was performed on the tah-t and did not reveal any anomalies or abnormalities and included an in-depth valve analysis including valve inspection, disc and housing analysis, and profilometry tracing of the discs.No valve stickiness was observed during the valve analysis.The device performed as intended with no evidence of a device malfunction.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4).

• Brand Name: SYNCARDIA 70CC TAH-T
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 7205968
• MDR Text Key: 97766588
• Report Number: 3003761017-2018-00001
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 104313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR