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

Model Number 305U227

Device Problems Calcified (1077); Material Puncture/Hole (1504); Material Too Rigid or Stiff (1544); Biocompatibility (2886); Material Twisted/Bent (2981); Naturally Worn (2988); Insufficient Information (3190); Material Split, Cut or Torn (4008)

Patient Problems Host-Tissue Reaction (1297); No Information (3190)

Event Date 04/29/2019

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 6 years and 11 months post implant of this bioprosthetic aortic valve, it was explanted for unknown reasons.The replacement product was not reported.No additional adverse patient effects were reported. .

Manufacturer Narrative

Upon receipt at medtronic's quality laboratory, visual examination revealed sewing ring damage that partially exposed the stent.This damage was consistent with damage occurring during the explant process.The valve was distorted, with the stent posts measuring 27.86 mm x 27.09 mm.The left-right stent was measured to be at 4°, the right non-coronary stent at 5°, and the left non-coronary stent at 6°.All leaflets were received in the open position.The leaflets were twisted.The leaflets were noted to be slightly stiff, but flexible, except where there was host tissue present.Striations in the outflow portion of all leaflets was thickened.On the belly of the left cusp, an abrasion was noted, which resulted in a hole.The abrasion appeared to be a result of contact with the bias cloth along the outflow rail.The right non-coronary and left-right commissures were intact.Pannus encapsulated the left non-coronary commissure.Pannus was also observed on the right-left inferior coaptation area and left cusp outflow rail.An unknown amount of pannus appeared to have been removed during explant.Radiography revealed multi-focal calcification on the right and left cusp outflow rail, as well as on all commissures.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No manufacturing issues were identified that would have impacted this event.Despite multiple attempts to the hospital to obtain additional information, it remains unknown why this product was explanted.Based on historical events, leaflet contact with the bias cloth can cause leaflet perforation and tearing.The tear and abrasions seen in the explanted valve may have led to regurgitation.It is unknown if the observed pannus contributed to the reason(s) for explant.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, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8591779
• MDR Text Key: 144445797
• Report Number: 2025587-2019-01507
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169001503
• UDI-Public: 00643169001503
• 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: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2017
• Device Model Number: 305U227
• Device Catalogue Number: 305U227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/08/2019
• Supplement Dates Manufacturer Received: 10/10/2019
• Supplement Dates FDA Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR