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

Model Number 500101-001

Device Problems Material Erosion (1214); Device Issue (2379)

Patient Problems Hemorrhage/Bleeding (1888); Liver Laceration(s) (1955)

Event Date 12/19/2017

Event Type  Injury  

Manufacturer Narrative

The tah-t will be 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 during exploratory surgery they determined that the cannulae of tah-t had eroded through the peritoneum into the dome of the left liver causing a liver laceration.The laceration caused slow bleeding into the mediastinum causing compression of the inferior vena cava.The customer also reported that the surgeons felt the only solution was to exchange the tah-t.The customer also reported that patient conditions (very thin and malnourished) contributed to the serious injury and they did not allege a device malfunction.The customer also reported that after the tah-t was replaced the patient was recovering well and "is like a whole new patient.".

Manufacturer Narrative

The cannulae were not returned with the tah-t ventricles and therefore could not be evaluated.An explant analysis was performed on the tah-t ventricles and did not reveal any anomalies or abnormalities.This issue will 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).

Event Description

The customer, a syncardia certified hospital, reported that during exploratory surgery they determined that the cannulae of tah-t had eroded through the peritoneum into the dome of the left liver causing a liver laceration.The laceration caused slow bleeding into the mediastinum causing compression of the inferior vena cava.The customer also reported that the surgeons felt the only solution was to exchange the tah-t.The customer also reported that patient conditions (very thin and malnourished) contributed to the serious injury and they did not allege a device malfunction.The customer also reported that after the tah-t was replaced the patient was recovering well and "is like a whole new patient.".

• 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: 7174874
• MDR Text Key: 96727512
• Report Number: 3003761017-2018-00004
• 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: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 110931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR