MAUDE Adverse Event Report: LIVANOVA CANADA CORP; TISSUE HEART VALVES

Device Problems Gradient Increase (1270); Material Deformation (2976)

Patient Problems Aortic Valve Stenosis (1717); Death (1802); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Ventricular Fibrillation (2130)

Event Date 02/21/2017

Event Type  Death  

Manufacturer Narrative

This event was reported to (b)(4) on 24-apr-2017 (mw5068924).A company representative has visited the hospital and delivered a formal letter requesting further information from the physician, no further information on this event has been received to date.At present limited information is known incl the device brand name and serial number.Device not returned to manufacturer.

Event Description

This event was reported to (b)(4) on 24-apr-2017 (mw5068924).On (b)(6) 2013, a sorin tissue valve size 19 was implanted.In 2014 an echo was performed and showed a peak systolic gradient of 45 mmhg with a mean gradient of 28 mmhg and normal lvef.The patient exhibited progressive dyspnea on exertion, limiting her functional capacity to nyha class ii-iii.In 2017 the patient exhibited worsening dyspnea on exertion.A repeat echo showed normal lyef, a peak systolic gradient estimated at 56-62 mmhg with a mean gradient of 36-40 mmhg without significant valvular or perivalvular aortic insufficiency.A cardiac cta showed normal coronary anatomy, no evidence of subvalvular obstruction or panus formation.The patient¿s symptoms failed to improve and deteriorated rapidly requiring urgent admission.A cardiac catheterization 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.A tee showed severely restricted aortic valve cusp opening with a peak gradient of 96 mmhg.Surgical aortic valve explantation and replacement was planned but the patient developed recurrent ventricular fibrillation and hemodynamic instability in the hospital while awaiting avr, the patient passed away on (b)(6) 2017.

Manufacturer Narrative

The manufacturer has made multiple attempts at retrieving further information on this event, with no further details provided to date.At present limited information is known including the device brand name and serial number.As the device has not been returned nor is the serial number known no investigation is possible at this time.Based on limited information received the root cause cannot yet be determined.

• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• Manufacturer (Section G): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 6586684
• MDR Text Key: 75814407
• Report Number: 3004478276-2017-00094
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

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?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 05/23/2017
• Supplement Dates Manufacturer Received: 12/04/2017
• Supplement Dates FDA Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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