MAUDE Adverse Event Report: LIVANOVA CANADA CORP MITROFLOW AORTIC PERICARDIAL HEART VALVE; TISSUE HEART VALVES

Model Number	DLA25
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aortic Regurgitation (1716)
Date of Event	10/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As per mitroflow aortic pericardial heart valve ifu -warnings a precautions "clinical experience described in the medical literature suggests that juvenile patients or patients who are undergoing chronic hemodialysis, who have parathyroid disease or impaired calcium metabolism, or who are 55 years of age or less may experience accelerated calcification of bioprosthetic heart valves.The valve was used in a pediatric case and did not follow the stated precautions." this event is for a patient of (b)(6).Not available for return.
Event or Problem Description
On oct 19, 2017 the manufacturer was notified through patient tracking of the following event.On (b)(6) 2017 a mitroflow aortic pericardial heart valve model dl was explanted due to severe regurgitation, from a patient under 55 years, the device had previously been implanted on (b)(6) 2014.A carbomedics reduced aortic valve r5-025 was then implanted.
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # dla25, s/n # (b)(4), were retrieved and reviewed by quality engineering at livanova (b)(4) corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a dla25 mitroflow aortic pericardial heart valve at the time of manufacture and release.Further information has been requested from the physician by the manufacturer, with no response to date.Based on limited information received the root cause cannot yet be determined.The device is not available for return or analysis, no further investigation is possible at this time.As per mitroflow aortic pericardial heart valve ifu -warnings a precautions "clinical experience described in the medical literature suggests that juvenile patients or patients who are undergoing chronic hemodialysis, who have parathyroid disease or impaired calcium metabolism, or who are 55 years of age or less may experience accelerated calcification of bioprosthetic heart valves." this event is for a patient of (b)(6) years.(please note correction in manufacturer's narrative from initial report - error stated in following "the valve was used in a pediatric case and did not follow the stated precautions." this event is for a patient of (b)(6) years." - this has now been corrected in narrative above to clarify the patient is (b)(6) years).

• Brand Name: MITROFLOW AORTIC PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• MDR Report Key: 7041369
• Report Number: 3004478276-2017-00189
• Device Sequence Number: 16580691
• Product Code: LWR
• UDI-Device Identifier: 00896208000184
• UDI-Public: (01)00896208000184(240)DLA25(17)160731
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Physician
• Device Expiration Date: 07/31/2016
• Device Model Number: DLA25
• Device Catalogue Number: DLA25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR