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

Model Number 40025

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2020

Event Type  malfunction  

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 both the barrel and replica ends of the sizing tool for this bioprosthetic aortic valve were used during the sizing process.Pledgets were placed, and the patient's valve was not re-sized after pledget placement.Upon attempting to implant the valve, the valve would not fully seat into the patient's annulus.The surgeon reported that the valve itself is "just a bigger valve" and that the valve seems larger than the sizer.It was reported that the surgeon "was set on getting in a 25 [mm valve] for this patient" and that the physician "tried to implant a larger valve [than the] aorta could handle".It was reported that the supporting stent of this valve is not as "deformable" as the stent of a different model valve the surgeon uses, and therefore could not fit into the annulus.A 25mm bioprosthetic valve with a more flexible stent was implanted instead.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that the valve was discolored showing evidence of blood contact with the sewing cuff appearing inverted.All leaflets were flexible.A small tear was noted on the edge of leaflet 3, which appears to have occurred during the explant process.All leaflets appeared to be in the closed position with a gap between leaflet 1 and leaflet 3.All commissures appeared intact.Using the validated production inspection fixture for this size and model of valve, the valve size was verified to align with a 25mm valve of this model.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.It was reported that the supporting stent of the valve is not as "deformable" as the stent of a different model of valve that the physician typically uses.Therefore, the valve could not fit into the patient's annulus.D9: 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 VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 11016336
• MDR Text Key: 223616007
• Report Number: 2025587-2020-03807
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169983205
• UDI-Public: 00643169983205
• 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: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2021
• Device Model Number: 40025
• Device Catalogue Number: 40025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 07/29/2021
• Supplement Dates FDA Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 99