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

Model Number DLA21

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Death (1802); Pulmonary Edema (2020); Respiratory Failure (2484)

Event Date 09/06/2016

Event Type  Death  

Manufacturer Narrative

This event was reported to the manufacturer through the sure-avr registry.Based on internal clinical assessment, the event was determined to be unknown if valve related.: device not explanted.

Event Description

A mitroflow dla21 was implanted on (b)(6) 2014 via median sternotomy.The valve was implanted supra-annular with non-everting suture technique with pledgets.On (b)(6) 2016, the patient had a sudden death.

Manufacturer Narrative

The complete manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # dla21, s/n # (b)(4), were pulled 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 dla21 mitroflow aortic pericardial heart valve at the time of manufacture and release.Based on the document review performed, no manufacturing deficits were identified.Additionally, follow-up with the site confirmed that the event was not device-related.Rather, the event was attributable to a previous failure in (b)(6) 2016 during which the patient underwent surgery for an abdominal hernia.As such, there is no known device problem, and no further investigation is required.Device not explanted.

Event Description

A dla21 was implanted on (b)(6) 2014 via median sternotomy.The valve was implanted supra-annular with non-everting suture technique.Pledget used.On (b)(6) 2016, the patient had a sudden death.The patient's death was attributed to sudden respiratory failure with pulmonary edema.It was reported that there was no link between the event and the device, and that the event was attributable to a previous failure in (b)(6) 2016 during which the patient underwent surgery for an abdominal hernia.The device was not explanted.

• Brand Name: MITROFLOW DLA
• 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: 7097936
• MDR Text Key: 94191873
• Report Number: 3004478276-2017-00205
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000160
• UDI-Public: (01)00896208000160(240)DLA21(17)190131
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P060038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

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
• Device Operator: Physician
• Device Expiration Date: 01/31/2019
• Device Model Number: DLA21
• Device Catalogue Number: DLA21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2014
• 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
• Patient Weight: 70