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

Model Number	DLA25
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Stroke/CVA (1770); Embolism (1829); Visual Disturbances (2140)
Date of Event	03/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, it appears that the patient was still under anticoagulation therapy with an inr of 2.7, which suggests the possibility that the patient may have anticoagulation disorders that could have caused or contribute to the event.However, the relationship with the device cannot be ruled out based on the information presently available thus the event is being reported in a conservative manner.Further investigation is ongoing and an update will be provided once additional information will be available.
Event or Problem Description
On (b)(6) 2013, a patient received a mitroflow dla25 in aortic position.On (b)(6) 2020, the patient experienced visual amaurosis, occlusion of the central retinal artery and transient ischemic attack (ischemic etiology).The patient is reportedly under a well-conducted anticoagulation therapy (previscan, inr 2.7).A transthoracic echocardiography was performed on (b)(6) 2020, which revealed the presence of tears in the pericardium of the device (3-4mm next to the non-coronary sinus and 11m in the valsalva sinus).On (b)(6) 2020, the patient underwent a re-do aortic valve replacement, and the dla25 valve was explanted.
Event or Problem Description
On (b)(6) 2013, a patient received a mitroflow dla25 in aortic position.On (b)(6) 2020, the patient experienced visual amaurosis, occlusion of the central retinal artery and ischemic stroke.The patient is reportedly under a well-conducted anticoagulation therapy (préviscan, inr 2.7).A transthoracic echocardiography was performed on (b)(6) 2020, which revealed the presence of tears in the pericardium of the device (3-4mm next to the non-coronary sinus and 11m in the valsalva sinus).On (b)(6) 2020, the patient underwent a re-do aortic valve replacement, and the dla25 valve was explanted.
Additional Manufacturer Narrative
Based on the performed analysis, it is not possible to verify if the tears object of the complaint refer to the large alterations observed on the returned device, which appeared consistent with a sampling action or implanting/explanting maneuver.Furthermore, the organic material identified during the investigation possibly suggests a deposition due to a progressive loss of contact between the pericardium sheet and external surface of the dacron covered stent.This loss of contact could be due to an interruption of the continuity of the thread (structural sewing connection) caused by: 1) alteration during the implanting procedure; 2) progressively deterioration during the working time; 3) alteration during the explanting procedure.Due to the alteration (reasonably due to the sampling) observed on the post #1 it is not possible to drawn definitive conclusions about the root cause of the claimed tear.Based on the available information, it appears that the patient was still under anticoagulation therapy with an inr of 2.7, which suggests the possibility that the patient may have anticoagulation disorders that could have caused or contribute to the reported visual amaurosis and cerebrovascular accident.However, since no further information was received and given the result of the device investigation, the root cause of event cannot be established.Structural valve deterioration is listed as a possible adverse event in the mitroflow ifu.The event is, therefore, a known inherent risk of the device.Fields updated: b4, d10, f7.Corrected sections: b5 (event description with proper translation of "avc ischémique" included).

• Brand Name: MITROFLOW DLA AORTIC PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 9996635
• Report Number: 3004478276-2020-00150
• Device Sequence Number: 2952771
• Product Code: LWR
• UDI-Device Identifier: 00896208000184
• UDI-Public: (01)00896208000184(240)DLA25(17)170531
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2020

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: 05/31/2017
• Device Model Number: DLA25
• Device Catalogue Number: DLA25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 06/24/2020
• 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