MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION AVALUS AORTIC TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 40023

Device Problems Perivalvular Leak (1457); Incomplete Coaptation (2507); Material Deformation (2976)

Patient Problems Host-Tissue Reaction (1297); Insufficiency, Valvular (1926)

Event Date 01/21/2020

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that immediately post implant of this 23mm bioprosthetic aortic valve, minimal paravalvular leak (pvl) was noted.Three months post implant the pvl progressed to mild.Ultimately 5 months post implant the valve was replaced with a 25mm aortic root valve.No additional adverse patient effects were reported. .

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed damage to the sewing ring that exposed the stent, likely occurring during the explant process.The stent posts appeared deflected.All leaflets were in the closed position with gaps between the free margins of all leaflets.All leaflets were slightly stiff but flexible, which is a normal finding for this valve.A remnant of off-white glistening pannus was observed on the inflow margin of attachment of one leaflet approaching the inferior coaptive area between two leaflets.Another remnant of glistening off-white pannus remained attached to the inflow sewing ring adjacent to the third leaflet.From the outflow, glistening off-white pannus appeared to be adhered to the commissural areas, creating the gaps observed between the leaflets.An unknown amount of pannus appears to have been removed during explant.Conclusions: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.With the available information, a conclusive cause of the paravalvular leak cannot be determined.Pvl can be caused by a variety of factors, including implant condition/technique, patient anatomy, or the presence of pre-existing patient conditions.It is possible that the valve may have been undersized during the initial implant procedure, which may have contributed to the pvl.D10: device available for evaluation updated h3: device evaluated? updated h6: coding updated medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AVALUS AORTIC TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9765401
• MDR Text Key: 181989044
• Report Number: 2025587-2020-00622
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169983199
• UDI-Public: 00643169983199
• Combination Product (y/n): N
• PMA/PMN Number: P170006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Model Number: 40023
• Device Catalogue Number: 40023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR