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); Syncope (1610); Aortic Valve Stenosis (1717)

Event Date 11/23/2015

Event Type  Injury  

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual inspection noted that the stent posts were slightly deflected.It was determined that the inflow orifice was damaged during explant with cuts and/or tears along the tissue and base stitching, exposing part of the stent.The right cusp was slightly stiff but flexible except where host tissue extended on the inflow and outflow.The non-coronary and left cusps were stiff due to host tissue on the outflow.The free margins of both cusps were received folded onto and adhered to the host tissue on the outflow.The right non-coronary and left non-coronary commissures were intact.A large remnant of pannus remained attached to the sewing ring on the inflow adjacent to the non-coronary cusp, over the tissue and base stitching, covering the inflow margin of the attachment of the non-coronary cusp extending slightly to the left and right cusps, into the right non-coronary and non-coronary left inferior coaptive areas and onto all cusps, showing evidence of a reduced inflow orifice area.Traces of pannus were observed in the left right inferior coaptive area.Pannus lined the sewing ring on the outflow, partially extending to all outflow rails and stent posts.It was determined that an unknown amount of pannus was removed on the inflow and/or outflow during explant.Tan thrombotic host tissue filled and stiffened the non-coronary and left cusps on the outflow.Tan thrombotic host tissue partially filled the belly of the right 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 analysis results of the device showed that the pannus overgrowth on the inflow 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 stenosis / high gradient.Based on the returned product analysis, the high gradient / stenosis are most likely caused by the pannus and thrombus.(b)(4).

Event Description

Medtronic received information that five months post implant of this 25 mm bioprosthetic aortic valve, the patient presented with syncope.Catheter and echocardiogram revealed increased gradients of 70 mmhg and showed that the leaflets were not moving properly.Angiogram revealed significant valvular flow acceleration, suggesting recurrent aortic stenosis.Six months post implant, this valve was explanted and replaced with a 23mm device.Gram stain testing revealed no organism growth.Prior to explant, on echocardiogram, one stent post looked bent; however, upon explant, it did not appear bent.Per the physician, the valve leaflets and stent appeared to be covered in fibrinous exudate.The physician stated that he does not attribute the reported issues to the valve.No adverse patient effects were reported.

• 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: 5308190
• MDR Text Key: 33832494
• Report Number: 2025587-2015-01336
• 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
• Report Date: 11/23/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2019
• Device Model Number: 305U
• Device Catalogue Number: 305U225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2014
• 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: 00068 YR
• Patient Weight: 85