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

Model Number 305U

Device Problems Gradient Increase (1270); Incomplete Coaptation (2507)

Patient Problems Corneal Pannus (1447); Congestive Heart Failure (1783)

Event Date 07/12/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product specimen has not been returned for device evaluation.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.

Event Description

Medtronic received information that 14 months post implant of this bioprosthetic valve, the patient presented with limited leaflet motion and gradients measuring 50mmhg, revealed by echocardiogram.The patient is in congestive heart failure (chf).The device has been explanted and replaced.Upon explant, pannus was revealed on the cusps of all leaflets with the heaviest appearing on the left coronary leaflet.No further adverse patient effects were reported.

Manufacturer Narrative

Conclusion: without the return of the device, the root cause cannot be determined.Based on the received information, the pannus overgrowth would have impaired the leaflet mobility leading to increased gradient.There are many studies which discuss the etiology of pannus.Pannus formation is patient dependent based on the possible underlying cause.Chronic pannus formation may be precipitated by an immune response to the bioprosthetic valve sewing ring and /or sutures and size of the bioprosthesis.It may also be caused by the presence of an injured endothelial surface potentially releasing fibroblast growth factor-2, blood flow turbulence, pregnancy and /or inadequate anti-coagulation.The time of pannus formation after valve implantation varies; studies have reported time frames from 6-12 months.The ingrowth of the tissue may gradually affect the function of the valve leaflets.Pannus overgrowth has been an inherent risk of surgical valve replacement.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.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the device arrived in a clear 0.2% glutaraldehyde solution in an explant kit.A piece of host tissue was received with the valve.The stent posts appeared slightly deflected.All leaflets were stiff due to host tissue on the inflow and outflow.All commissures appeared intact.A large remnant of pannus remained attached to the sewing ring adjacent to the left cusp, over the tissue and base stitching, to the left right inferior coaptive area, extending along the inflow margin of attachment and 1 to 4 mm onto both the left and right cusps showing a reduced inflow orifice area.A piece of pannus was received with the valve.Pannus lined the sewing ring on the outflow extending slightly onto the outflow rail adjacent to the non-coronary cusp and top of the right non-coronary stent post.An unknown amount of pannus appeared to have been removed on the inflow and outflow during explant.Tan thrombotic appearing host tissue filled and stiffened all cusps on the outflow.Radiography showed no mineralization in the valve and/or host tissue.Conclusion: the device was returned for analysis.Visual inspection was performed on the returned device.The pannus overgrowth on the inflow appears to have extended several millimeters out onto the leaflet which would have significantly impaired the leaflet mobility (coaptation).The impairment of leaflet mobility may have led to the thrombus formation on the outflow of the valve causing the high gradient.High gradients due to immobile leaflets caused by pannus overgrowth / thrombus is a known failure mode and is addressed in the current risk management file.

Manufacturer Narrative

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
• 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: 5831600
• MDR Text Key: 50712461
• Report Number: 2025587-2016-01159
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/14/2017

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: 02/04/2020
• Device Model Number: 305U
• Device Catalogue Number: 305U229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2016
• Initial Date FDA Received: 07/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 03/14/2017
• Supplement Dates FDA Received: 08/09/2016; 03/16/2017; 03/22/2017; 09/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2015
• 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
• Patient Age: 75 YR
• Patient Weight: 93