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

Model Number 305U223

Device Problems Calcified (1077); Gradient Increase (1270); Occlusion Within Device (1423); Incomplete Coaptation (2507)

Patient Problems Chest Pain (1776); Dyspnea (1816)

Event Date 09/04/2014

Event Type  Injury  

Manufacturer Narrative

Based on the analysis observation, it appears that the valve may have been distorted during implant, which created localized stress during the closure on the commissures and caused leaflet misalignment.The leaflet misalignment then created a space (pocket) for blood accumulation (thrombus).Histopathology confirmed thrombus and calcification.A review of the device history record was also performed for this valve.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.The high gradient was most likely caused by the valve distortion, which could lead to insufficient effective orifice area, an immobile leaflet, and compromised forward flow.Exactly when and how the distortion occurred cannot be determined; however per manufacturing procedures, each mosaic valve is inspected for distortion and this valve passed the inspection prior to release for distribution.

Event Description

Medtronic received information that high gradients, aortic stenosis and trace regurgitation were observed via echocardiogram during the patient¿s six-month post-implant follow-up.One month later, the physician elected to explant the device due to the patient being symptomatic with dyspnea, chest pain and occasional arm/shoulder pain.Upon explant, two of the valve cusps were largely immobile, with what appeared to be calcification extending from the cusps to the device base.No subsequent adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, the initial visual observation noted that the valve was distorted in an oval shape.A leaflet appeared to have been cut or torn.The sewing ring appeared to have been removed during explant, exposing part of the stent.A metal-like pledget remained crimped to a green multifilament suture on the outflow adjacent to the non-coronary left stent post.All existing leaflets were slightly stiff but flexible, except where host tissue and/or mineralization extended on the outflow.A section of the left cusp appeared to have been excised for histopathology sampling.A small tear or puncture through the tunica of the non-coronary cusp along the inflow margin of attachment appeared to be associated with the removal of host tissue during explant.The non-coronary left and left-right commissures were intact.Cuts and/or tears observed on the right non-coronary commissure appeared to have occurred during explant.A remnant of glistening off-white pannus remained attached to the inflow margin of attachment adjacent to the left-right inferior coaptive area.Pannus remained attached to the outflow rail adjacent to all cusps extending to both the non-coronary left and left-right stent posts.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 the non-coronary cusp on the outflow with remnants lining the right cusp and existing left cusp.Radiography showed trace mineralization in all cusps.Histopathological examination of the returned valve showed moderate to severe extrinsic calcification of the left coronary cusp, and mild multi-focal extrinsic calcification of the right coronary and non-coronary cusps.There was minute focal intrinsic calcification of the left coronary leaflet.Thrombus was observed on the outflow surface of all leaflets.There was no evidence of infection in the examined samples.

Manufacturer Narrative

The product has been returned and analysis is in progress.Upon completion of analysis, a supplemental report will be submitted.(b)(4).

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 STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4190600
• MDR Text Key: 12710381
• Report Number: 2025587-2014-00778
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2018
• Device Model Number: 305U223
• Device Catalogue Number: 305U223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2013
• 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): Other; Required Intervention
• Patient Age: 00055 YR