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 Problems Bowel Perforation (2668); Multiple Organ Failure (3261)

Event Date 05/08/2015

Event Type  Death  

Manufacturer Narrative

The article reports a case of pulmonary artery outflow obstruction secondary to tamponade caused by a leak of the surgical anastomosis.This event resulted in rapid deterioration of the patient's condition and required surgical intervention to evacuate the hematoma and restore hemodynamic stability.The patient's coagulation was within therapeutic range at the time.The article was written to report the ct protocol that was used to produce diagnostic quality ct images that enabled timely diagnosis and intervention of this life threatening tah complication.The tah did not directly cause or contribute to the pulmonary artery outflow obstruction (tamponade) but the "presence of" or "surgical implantation of" the tah resulted in the pulmonary artery outflow obstruction.As indicated in the summary, the tamponade which led to the hemodynamic and respiratory decline of the patient was caused by the accumulation of blood that compressed the pulmonary artery outflow graft resulting from a leak in the anastomosis (a surgical connection) from the tah implant surgery.Even though the anticoagulation was in a therapeutic range, the anticoagulation of the patient required because of the presence of the tah may have contributed to the anatomic leak (bleeding) surgical connection(s) of the tah resulting in the accumulation of blood in the chest.Based on the information provided in the article, syncardia was able to make a one to one correlation.Per the syncardia heart tracking explant form provided by the hospital, the patient subsequently died from ischemic bowel and multi-system organ failure.(b)(4) initial.

Event Description

Case report in minneapolis heart institute foundation, total artificial heart right ventricular outflow graft obstruction by thomas knickelbine, md, benjamin sun, md et.Al.Published in journal of the minneapolis heart institute foundation, volume 2, issue 1, spring/summer 2018.The article reported a case of a (b)(6) year-old woman with end-stage hypertrophic cardiomyopathy and severe pulmonary hypertension who presented with refractory cardiogenic shock and renal failure.Her condition necessitated mechanical ventilation and initiation of continuous renal replacement therapy (crrt).Her renal failure and pulmonary hypertension did not improve despite normalization of filling pressures.Her persistent renal failure and pulmonary hypertension prevented her from being listed for heart transplantation.She was not a candidate for left ventricular therapy because of her high risk for developing right ventricular failure.Therefore, she was implanted with the syncardia total artificial heart (tah).Following implantation of the tah, she was successfully weaned from the ventilator but remained on crrt.On post-operative day nine, she exhibited a significant decrease in her ventricular ejection volume and rapidly progressing hypoxemia requiring emergent reintubation.The chest x-ray and laboratory values were unremarkable, and her coagulation was in a therapeutic window (aptt 65 seconds, fibrinogen 743 mg/dl, inr 1.4).Her central venous pressure (cvp) was 8-12 mg hg.A ct scan using a protocol described by winkler et.Al., revealed an extrinsic compression of the pulmonary arterial graft by a large hematoma (blood) resulting in a right outflow valve obstruction.The patient was urgently taken to the operating room for exploration and evacuation of a large hematoma that resulted in instantaneous improvement in both the right- and left-sided flows and right-sided ejection.The hematoma was thought to be secondary to anastomotic leak.The obstruction (tamponade of the pulmonary artery graft) prevented the tah from effectively pumping blood, resulted in rapid hemodynamic deterioration and required immediate detection and intervention.The ct imaging protocol used in this case resulted in diagnostic quality images that helped guide the definitive surgical management of the patient.

• 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 Contact: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 8982618
• MDR Text Key: 157331514
• Report Number: 3003761017-2019-00273
• 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: literature
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 096910
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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): Death
• Patient Age: 54 YR