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

Model Number 305U225

Device Problems Gradient Increase (1270); Occlusion Within Device (1423); Perivalvular Leak (1457)

Patient Problems Aortic Valve Stenosis (1717); Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Hemorrhage/Bleeding (1888); Thrombus (2101)

Event Date 10/27/2014

Event Type  Injury  

Event Description

Medtronic received information that approximately 55 weeks after implant, this bioprosthetic valve was explanted due to severe aortic stenosis and high gradients.At explant, it was observed that there was thrombus or debris in the bellies of the valve.It also was reported that the implant of the valve was via minimal invasive approach through a right thoracotomy.Following implant, a mild-to-moderate paravalvular leak was noted.The patient was placed back onto bypass, and additional sutures were placed to resolve the paravalvular leak.The patient exhibited exertional dyspnea, fatigue and chest pain, which may have been related to the placement of the additional sutures.It also was reported that the patient, who has factor v leiden deficiency, exhibited venous bleeding during the operation, which was resolved during the implant procedure.

Manufacturer Narrative

It was reported that the device will be returned for analysis.A supplemental report will be filed when the analysis/investigation is completed.(b)(4).

Manufacturer Narrative

The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.It was reported that the device return for analysis is pending.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, the device was in a clear 0.2% glutaraldehyde solution in an explant kit.Visual inspection revealed the valve to be distorted; oval shaped.Part of the sewing ring was removed during explant.Small needle holes along the existing sewing ring show placement of implantation sutures.Pledgets remained attached to the existing sewing ring and remnant of host tissue received with the valve.All leaflets were slightly stiff but flexible, except where host tissue extended on the outflow.Tears observed on the tunica of all cusps along the inflow margin of attachment were determined to be associated with the removal of host tissue during explant.The free margin of all cusps were received folded back towards the belly of the cusps.The free margin of the non-coronary cusp was received folded back and adhered to the host tissue on the outflow.All commissures were intact.A remnant of pannus remained attached to the sewing ring on the inflow, adjacent to the left cusp.A remnant of pannus was received with the valve.Traces of pannus remained attached to the existing sewing ring, outflow rails and stent posts.It was determined that an unknown amount of pannus was been removed on the inflow and outflow during explant.Tan thrombotic appearing host tissue filled and stiffened the right and non-coronary cusps on the outflow, with remnants on the outflow of the left cusp.Radiography showed no evidence of mineralization in the valve and/or host tissue.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The distortion found on the returned device is consistent with a sizing issue and/or squeezing of the stent during implant.Based on the received information and the returned product analysis, the severe aortic stenosis and high gradient could have resulted in the abundant thrombus filling the cusp outflow that caused an immobile leaflet issue.In addition, valve distortion could also cause the leaflets to become immobile, and lead to stenosis / high gradient.Exactly when and how the distortion occurred cannot be determined; however each device is inspected for distortion and this valve passed the inspection prior to release for distribution.Medtronic will continue to monitor field performance for similar events should they occur.

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: 4270833
• MDR Text Key: 5031796
• Report Number: 2025587-2014-00919
• 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: 02/17/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2018
• Device Model Number: 305U225
• Device Catalogue Number: 305U225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2015
• Initial Date FDA Received: 11/21/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 02/17/2015
• Supplement Dates FDA Received: 12/12/2014; 02/26/2015; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2013
• 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): Required Intervention
• Patient Age: 00069 YR
• Patient Weight: 87