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

Model Number 305U

Device Problem Gradient Increase (1270)

Patient Problem Valvular Stenosis (2697)

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product specimen has been returned for analysis; however, the evaluation is still in progress.Conclusion: upon conclusion of the product analysis and investigation, a supplemental report will be submitted.

Event Description

Medtronic received information that 1 year and 8 months post implant of this bioprosthetic valve, a transesophageal echocardiogram (tee) showed increased gradients and moderate stenosis.One year and 11 months post implant, the patient presented with a mean gradient of 56mmhg.The physician explanted and replaced the device with a non-medtronic product.No further adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the valve appeared slightly distorted with one stent post deflected.All leaflets were stiff due to host tissue on the outflow.Tears on the tunica of the right and non-coronary cusps adjacent to the inflow margin of attachment appeared to be associated to the removal of host tissue during explant.The tunica of the left cusp appeared intact.The free margins of the non-coronary and left cusps folded back, adhering to the host tissue on the outflow.All commissures appeared intact.A long remnant of glistening off white pannus lined the inflow margin of attachment adjacent to the non-coronary cusp extending slightly into the non-coronary left inferior coaptive area, and 1 to 2 mm onto the non-coronary cusp showing a possible reduced inflow orifice area.Traces of pannus were observed on the outflow.An unknown amount of pannus appeared to have been removed on the inflow during explant.Tan thrombotic appearing host tissue filled and stiffened all leaflets on the outflow.Brown discoloration in the tunica along the inflow margin of attachment extending to the tissue and base stitching suggested prior hemorrhage or blood accumulation.Radiography showed no evidence of mineralization in the valve and/or host tissue.Conclusion: the pannus overgrowth on the inflow appeared to have extended several millimeters out onto the leaflet which would have significantly impaired the leaflet mobility.The impairment of leaflet mobility may have led to the thrombus formation on the outflow of the valve causing the high gradient / stenosis.In addition, distortion of the annular ring can restrict the leaflets from fully opening and potentially causing the high gradient.Pannus overgrowth is associated with surgical valve replacement due to patient interaction and/or healing response with the surgical valve.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-coag ulation.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 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: 6393294
• MDR Text Key: 69555428
• Report Number: 2025587-2017-00376
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00613994760593
• UDI-Public: 00613994760593
• 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
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2015
• Device Model Number: 305U
• Device Catalogue Number: 305U227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2010
• 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: 79 YR
• Patient Weight: 85