MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION VALVE 305C2J27 MOSAIC AOR CINCHII JAPAN; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 305C2J27

Device Problems Calcified (1077); Degraded (1153); Fracture (1260); Perivalvular Leak (1457); Material Puncture/Hole (1504); Incomplete Coaptation (2507); Biocompatibility (2886); Material Twisted/Bent (2981); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Aortic Regurgitation (1716)

Event Date 02/03/2020

Event Type  Injury  

Manufacturer Narrative

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 7 years and 6 months post implant of this 27mm aortic bioprosthetic valve, it was explanted and replaced with a non-medtronic valve due to aortic regurgitation (ar) and paravalvular leakage.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that all commissures appeared intact and all leaflets appeared slightly twisted, in the closed position, with a gap between the right cusp and left cusp coaptive ridges.All leaflets were slightly stiff but flexible except in areas where host tissue extended onto the inflow, which is a normal finding for this valve.Leaflet deterioration resulting in a hole was observed on the lunula of the left cusp.The abrasion appeared to be due to contact with the inner outflow rail.An approximate 3mm abrasion was noted on the free margin of the non-coronary cusp.Pannus remained attached to the sewing ring on the inflow adjacent to the non-coronary cusp extending up to 8mm of the non-coronary cusp reducing the inflow orifice area.Pannus remained attached to the base stitching and inflow margin of attachment of the right cusp extending up to 9mm onto the non-coronary right inferior coaptive area.An unknown amount of pannus may have been removed during explant.Radiography revealed calcification on the right outflow rail.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.Each valve of this type is visually verified under a microscope for leaflet punctures and tears.Deflection of the stent posts can result in more contact of the leaflet with the cloth due to the altered position of the outflow rail and stent posts.Exactly when and how the stent deflection occurred cannot be determined.Each valve of this type is visually verified that there is no irregular bending of the stent posts prior to release for distribution.The tear and abrasions seen in the explanted valve may have been a result of the altered position of the outflow rail.Calcification is a common cause for regurgitation.Pannus can also impact normal valve movement and can distort the shape, resulting in wear in atypical places on the valve and, in this case, causing the abrasion on the inner outflow rail.Paravalvular leak can be caused by a variety of factors, including implant condition/technique, patient anatomy, or presence of pre-existing patient conditions.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: VALVE 305C2J27 MOSAIC AOR CINCHII JAPAN
• 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: 9697636
• MDR Text Key: 189187321
• Report Number: 2025587-2020-00444
• 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: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2014
• Device Model Number: 305C2J27
• Device Catalogue Number: 305C2J27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• 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: 60 YR
• Patient Weight: 78