MAUDE Adverse Event Report: SORIN SORIN PERICARDIAL TISSUE VALVE #19

Model Number 19

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

Patient Problems Death (1802); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Left Ventricular Dysfunction (1947); Pulmonary Dysfunction (2019); Ventricular Fibrillation (2130)

Event Date 02/21/2017

Event Type  Death  

Event Description

Patient presented with severe, symptomatic calcific aortic stenosis requiring aortic valve replacement on (b)(6) 2013.The aortic valve was replaced with a #19 soin pericardial tissue valve without complications.She did not require concurrent cabg since she had not underlying cad.She fully recovered and maintained nyha functional class i for approximately 40-42 months post op.An echocardiogram done (b)(6) 2014 showed a peak systolic gradient of 45 mmhg with a mean gradient of 28 mmhg and normal lvef.The peak rvsp was estimated at 25 mmhg and the mean pulmonary artery pressure 11 mmhg.She then developed progressive dyspnea on exertion limiting her functional capacity to nyha class ii-iii.She was seen for worsening dyspnea on exertion on (b)(6) 2017.A repeat echocardiogram on (b)(6) 2017 showed normal lvef, a peak systolic gradient estimated at 56-62 mmhg with a mean gradient of 36-40 mmhg without significant valvular or perivalvular aortic insufficiency.The peak rvsp was now estimated at 53 mmhg.A cardiac cta (b)(6) 2017 showed normal coronary anatomy without significant cad, mild reduction in the lvef measured at 47 percent and no evidence of subvalvular obstruction or panus formation.She underwent comprehensive pulmonary evaluation of (b)(6) 2017 showing an fev1 of 1.02 l and an fvc of 1.47 l.Her symptoms failed to improve following combination diuretic therapy with furosemide and metolazone.Her symptoms deteriorated rapidly requiring urgent admission on (b)(6) 2017.A cardiac catheterization on (b)(6) 2017 showed a peak to peak gradient across the aortic valve of 96mmhg with markedly elevated lved measured at 38 mmhg.She also demonstrated severe pulmonary hypertension with a pa pressure of 91/9 mmhg with a mean of 49 mmhg with low cardiac index measured at 1.7 l/min/m2.A tee done on (b)(6) 2017 showing severely restricted aortic valve cusp opening with a peak gradient of 96 mmhg.Surgical aortic valve explantation and replacement was planned for (b)(6) 2017.Unfortunately, the patient developed recurrent ventricular fibrillation and hemodynamic instability in the hospital while awaiting avr, expiring on (b)(6) 2017.These clinical findings are consistent with rapidly deteriorating bioprosthetic valve malfunction.

• Brand Name: SORIN PERICARDIAL TISSUE VALVE #19
• Type of Device: SORIN PERICARDIAL TISSUE VALVE #19
• Manufacturer (Section D): SORIN
• MDR Report Key: 6463317
• MDR Text Key: 72078620
• Report Number: MW5068924
• Device Sequence Number: 1
• Product Code: LWR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2017

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Weight: 101