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

Model Number TBD

Device Problem Degraded (1153)

Patient Problems Aortic Regurgitation (1716); Heart Failure (2206)

Event Type  Injury  

Manufacturer Narrative

Since the device was not explanted (valve-in-valve performed) and the serial number is unknown at this time, the manufacturer was unable to perform any investigation.As such, it is not possible to determine the root cause of the reported event.The manufacturer has followed up to retrieve additional information on this event and, if received, a follow up report will be submitted.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.

Event Description

The manufacturer was informed on this event through the recent publication 'valve-in-valve transcatheter aortic valve implantation with accurate neo for a degenerated bio-bentall'.A (b)(6) man with heart failure was referred to the hospital for recurrent episodes of acute heart failure.Transesophageal echocardiography revealed severe aortic regurgitation due to a degenerated bio-bentall mitroflow 27mm.The heart team decided for a valve-in-valve (viv) transcatheter aortic valve implantation with an acurate neo m associated with coronary protection due to a high risk of coronary obstruction (co).The patient remained stable during the procedure with an uncomplicated postoperative course.The post-procedural ct scan documented good positioning of both coronary stents and of the prosthesis.Pre-discharge echo also confirmed good performance of the prosthetic valve.Besides the supra-annular design, this case shows additional potential advantages of the accurate neo in viv procedures: the upper crown, which is meant to favor supra-annular anchoring, also let to cap the bioprosthesis leaflets and minimize the risk of co; there is not any interference between the valve cage and the stents protruding into the aorta, avoiding potential stent crushing and assuming an easier future coronary engagement.

Manufacturer Narrative

Fields changed: date of report, description of event or problem, premarket identification, type of report, type of reportable event, follow up type, adverse event problem.Based on the additional information received, the patient received the mitroflow prosthesis in another hospital and no further information can be provided on the event.Since the device was not explanted and since the serial number is unknown, no investigation is possible at this time.As such, the root cause of the event remains unknown.It should be noted that 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.During the follow up, the manufacturer was also informed that the patient had an endocarditis which required the explant of the device previously implanted (mitroflow 25, model unknown).Since the manufacturer is unable to follow up further on this event, and giving that no investigation is possible at this time, the root cause of this event cannot be established.It should be noted that endocarditis is listed as a possible adverse event in the mitroflow ifu.The event is, therefore, a known inherent risk of the device.If additional information will be made available in the future, proper investigative actions will be taken and a separate report will be submitted.

Event Description

Per additional information received, the patient was admitted to the centre only for the tavi procedure, which was performed in (b)(6) 2019.The diagnosis of degeneration was determined a few weeks before that.The patient underwent a bentall procedure in (b)(6) 2011 with a mitroflow 25.Then, the patient had endocarditis and had another surgery in (b)(6) 2012.The explanted prosthesis mitroflow 25 was replaced with a mitroflow 27.Since the device was implanted in another hospital, the other information (prothesis sn, etc) is not available.

• Brand Name: MITROFLOW AORTIC PERICARDIAL HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 9396940
• MDR Text Key: 170039611
• Report Number: 3004478276-2019-00324
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 12/29/2019

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: Health Professional
• Device Model Number: TBD
• Device Catalogue Number: TBD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 12/04/2019
• Supplement Dates FDA Received: 12/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR