MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, REPLACEMENT

Model Number 305U221

Device Problems Calcified (1077); Degraded (1153); Material Puncture/Hole (1504); Material Separation (1562); Inadequacy of Device Shape and/or Size (1583); Material Twisted/Bent (2981); Mechanics Altered (2984); Naturally Worn (2988); Material Split, Cut or Torn (4008)

Patient Problems Host-Tissue Reaction (1297); Aortic Valve Stenosis (1717)

Event Date 03/05/2020

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 an unknown duration post implant of this bioprosthetic aortic valve, it was explanted and replaced with a non-medtronic device.The reason for replacement was due to stenosis and patient prosthesis mismatch.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that all leaflets were slightly twisted and in the closed position.All leaflets were slightly stiff but flexible, which is a normal finding for this valve.An approximately 6mm deterioration resulting in a tear was noted on the lunula of the right cusp near the right/left commissure.Additionally, the tissue on the left cusp margin of attachment was deteriorated, creating a gap between the leaflet and the stent post.Leaflet abrasion resulting in a hole was observed on the lunula of the left cusp.The abrasion appeared to result from contact with the inner outflow rail.The start of a commissure dehiscence was noted on the right/left commissure area with the tissue deterioration on the right and left cusps.The right/non-coronary and left/non-coronary commissures were intact.Remnants of off-white pannus remained attached to the sewing ring.Off-white pannus was noted on the top of the right/non-coronary stent post.An unknown amount of pannus may have been removed during the explant process.Radiography revealed calcification on the right/left and left/non-coronary commissural areas.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.Structural valve deterioration is a known failure mode for bioprosthetic heart valves, especially as the device ages.The stenosis is most likely caused by the pannus, which was confirmed on the returned valve and is often considered a patient-related condition.Pannus is also the likely source of the abrasions.The observed calcification is also considered a patient-related condition.Correction to b5: the valve was replaced 7 years and 1 month post implant.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: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, REPLACEMENT
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9927376
• MDR Text Key: 186818145
• Report Number: 2025587-2020-01129
• Device Sequence Number: 1
• Product Code: DYE
• UDI-Device Identifier: 00613994760647
• UDI-Public: 00613994760647
• Combination Product (y/n): N
• PMA/PMN Number: P990064
• 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: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2015
• Device Model Number: 305U221
• Device Catalogue Number: 305U221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 95