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

Model Number 305UJ27

Device Problems Material Distortion (2977); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Pannus (1447); Aortic Regurgitation (1716); Calcium Deposits/Calcification (1758); Hematoma (1884); Cusp Tear (2656)

Event Date 09/25/2017

Event Type  Injury  

Manufacturer Narrative

The product has been returned and analysis is in progress.Upon completion of analysis, a supplemental report will be submitted.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.

Event Description

Medtronic received information that 13 years post implant of this aortic bioprosthetic valve, there was a tear at the noncoronary cusp which resulted in regurgitation.The device was explanted and replaced.No additional adverse patient effects were reported. .

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, visual examination showed the valve was slightly distorted; oval shaped.The non-coronary cusp was in the closed position.The left and right cusps were in the open position.All leaflets were stiff but slightly flexible except where calcification was noted.Tissue deterioration due to visible calcification was observed on all leaflets near the commissures.An intracuspal hematoma was noted on inflow aspect of the non-coronary leaflet.Tissue deterioration due to visible calcification was present on all commissures.A small amount of pannus was noted on the superior coaptive area of all commissures.There was no evidence of commissure dehiscence.Pannus lined the sewing ring on the inflow adjacent to the right and left cusps, extending over the base stitching, to the inflow margin of the attachment, encroaching 1 mm to 8 mm on to the cusps and into the inferior coaptive areas between the right and left cusps.Remnants of a thin layer of pannus was observed on the sewing ring (inflow aspect) extending to the outflow rails and stent posts.An unknown amount of pannus appeared to have been removed on the inflow and outflow during explant.Radiography confirmed calcification at the commissures.Reduced performance of the valve is attributed to host tissue overgrowth.This finding is generally considered a patient-related condition.Serial number and expiration date added.Manufacturing date added.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
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e. deere ave.; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6970574
• MDR Text Key: 90025550
• Report Number: 2025587-2017-01904
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

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: 04/14/2009
• Device Model Number: 305UJ27
• Device Catalogue Number: 305UJ27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/23/2017
• Supplement Dates Manufacturer Received: 11/14/2017
• Supplement Dates FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention