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

Model Number	DLA21
Medical Device Problem Codes	Calcified (1077); Gradient Increase (1270); Material Too Rigid or Stiff (1544); Material Deformation (2976)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	10/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device location not presently known.
Event or Problem Description
On (b)(6) 2014, the patient received a mitroflow valve to replace his native aortic valve which became stenotic.On (b)(6) 2016, a structural valve deterioration due to leaflet's calcification was identified.This event lead to re-operation of the patient on (b)(6) 2016, in which occasion the mitroflow valve was explanted and replaced with a mechanical valve.
Additional Manufacturer Narrative
As the device was not available for return, no device analysis could be performed.However, review of the device history record confirmed that the valve satisfied all material, visual and performance standards required for a dla21 at the time of manufacture and release.Analysis of the patients height and weight indicate moderate patient-prosthesis mismatch.Review of the patient history revealed that the patient was diabetic at the time of implant.Based on the investigation performed, no manufacturing deficiencies were identified.The patient's risk factors (diabetes) may have predisposed the patient to structural valve deterioration.Moreover, moderate patient-prosthesis mismatch suggests that procedural error may have played a role in the accelerated deterioration of the valve.
Event or Problem Description
On (b)(6) 2014, a patient received a mitroflow valve to replace his native aortic valve which has become stenotic.On (b)(6) 2016, structural valve deterioration with leaflet calcification was identified.This event lead to re-operation of the patient on (b)(6) 2016, during which the mitroflow valve was explanted and replaced with a mechanical valve.It was reported that calcification was identified on 3 cusps of the valve and there was a shrinking effect.The valve was not available for analysis.

• Brand Name: MITROFLOW DLA AORTIC PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANDA CORP; 5005 north fraser way; burnaby, british columbia V5J5M 1; CA V5J5M1
• MDR Report Key: 7904185
• Report Number: 3004478276-2018-00296
• Device Sequence Number: 148459
• Product Code: LWR
• UDI-Device Identifier: 00896208000160
• UDI-Public: (01)00896208000160(240)DLA21(17)190531
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2018

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: Health Professional
• Device Expiration Date: 05/05/2019
• Device Model Number: DLA21
• Device Catalogue Number: DLA21
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 10/28/2018
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 104