MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC ULTRA PORCINE HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 305U2J21

Device Problems Calcified (1077); Degraded (1153); Gradient Increase (1270); Material Separation (1562); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

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

Event Date 03/09/2020

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 25mm aortic bioprosthetic valve, it was explanted and replaced with a non-medtronic valve due to high gradient measurements and aortic stenosis (as).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 exposing the stent, likely a result of the explant process.All leaflets were twisted, in the closed position, and were slightly stiff but flexible except where host tissue extends on the inflow.Leaflet deterioration was noted in the lunula of the right cusp, likely resulting from the calcification revealed via radiography.A small leaflet tear was noted on the free margin of the right cusp distal to the right/left commissure.An approximate 4mm leaflet tear was observed on the left cusp near the left/non-coronary commissure.The start of a commissure dehiscence was observed on the left/non-coronary commissure, possibly related to separation of the layers of aortic wall behind the commissure.The right/non-coronary commissure was intact.Off-white pannus remnants remained attached to the existing sewing ring, with pannus extending from the non-coronary outflow rail.An unknown amount of pannus may have been removed during explant.Radiography revealed calcification on right cusp.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.The common probable cause for high gradients and stenosis is due to pannus overgrowth, which was confirmed with the returned valve.Pannus growth and calcification can impact the valve¿s normal function, resulting with tears in the leaflets and the onset of commissure dehiscence.Calcification and pannus are inherent risks of surgical valve replacement which are normally considered to be patient-related conditions.Brand name updated product code updated model #, catalog #, expiration date, serial #, udi # device available for evaluation updated device evaluated? updated device mfg date added 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 ULTRA PORCINE HEART 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: 9848302
• MDR Text Key: 183928195
• Report Number: 2025587-2020-00825
• Device Sequence Number: 1
• Product Code: LWR
• 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,foreig
• 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: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2015
• Device Model Number: 305U2J21
• Device Catalogue Number: 305U2J21
• 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: 82 YR