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

Model Number 305C225

Device Problem Structural Problem (2506)

Patient Problem Regurgitation (2259)

Event Date 06/17/2014

Event Type  Injury  

Event Description

Medtronic received information that eight months post implant of this bioprosthetic valve, this valve was explanted due to central regurgitation and replaced with a non-medtronic valve.No adverse patient effects were reported.The product has been retained by the facility and will not be returned for analysis.

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.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Should the product be returned, a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

Explanted date added to this report - it was inadvertently excluded from the initial report.Photos of the explanted device were sent to and reviewed by medtronic.Based on the review of the photos, host tissue (pannus) was observed on the inflow of the valve.However, the image quality of the outflow was poor.It is difficult to draw a definitive conclusion based on the received photograph.Pannus overgrowth is an inherent risk of surgical valve replacement.Based on the limited information received, the cause of regurgitation still cannot be determined.

Manufacturer Narrative

Additional information was received via the operative report that this bioprosthetic valve was implanted in a patient with a bicuspid aortic valve to treat moderate to severe central aortic insufficiency.Post-implant, a small paravalvular leak was noted around the valve; no central regurgitation was noted.The operative report indicated that this was a minor finding without hemodynamic significance.Approximately 6 weeks prior to the valve explant, sinus symptoms of recurrent congestive heart failure (chf) were noted.A transesophageal echocardiogram (tee) suggested central regurgitation could be the cause of the symptoms.During explant, no gross abnormalities were noted.The valve was explanted by cutting the valve out or dividing the stitches where possible.The bioprosthetic valve was replaced with a mechanical valve.Per the facility's surgical pathology report, gross examination of the explanted device noted that two of the cusps met smoothly, and at one junction of two cusps there was an opening where the cusps did not meet.There was no evidence of vegetation or calcification.The explanted device has been returned.Device analysis and investigation are ongoing.A supplemental report will be filed upon completion of the analysis and investigation.(b)(4).

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the returned product specimen was evaluated.All leaflets were slightly stiff but flexible except where host tissue extended on the inflow and outflow.The right coronary and non-coronary cusps appeared to be intact.The outflow aspect were observed with the left and right cusps slightly elongated and the non-coronary cusp slightly narrowed; this may have been associated with the distorted appearing stent and stent posts.All commissures appeared intact.A large remnant of tan pannus adjacent to the left and right cusps remained attached to the sewing ring on the inflow, extending over the tissue and base stitching, into the left right inferior coaptive area and 1 to 3.5 mm onto both cusps.This revealed a possible reduced inflow orifice area.A remnant of pannus remained attached to the tissue and base stitching adjacent to the non-coronary and left cusps extending into the non-coronary left inferior coaptive area and 1 to 1.5 mm onto the both cusps.Pannus lines the existing sewing ring on the outflow, extending to the back of the left right stent post, to the outflow rail adjacent to the right cusp th en covering the outflow margin of attachment.Traces of pannus remained attached to the outflow rail adjacent to the non-coronary and left cusps.An unknown amount of pannus appeared to have been removed on the inflow and/or outflow during explant.Remnants of tan thrombotic appearing host tissue was observed along the belly of the non-coronary and left cusps.Traces of tan thrombotic appearing host tissue lined the right cusp on the outflow adjacent to the outflow margin of attachment.Radiography showed no evidence of mineralization in the valve and/or host tissue.Conclusion: this investigation is ongoing.Upon the completion of investigation, a supplemental will be submitted.

Manufacturer Narrative

Investigation conclusion: based on the information received and the analysis observations, the pannus overgrowth in the leaflet's attachment site could have pulling the leaflet open.Also, the distortion of the valve could have been another contributing factor resulting in the device not fully coapting.A review of the device history record (dhr) was 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 regurgitation is most likely attributed to the valve distortion and the pannus overgrowth, which could lead to leaflets not coapting fully.Reduced performance of the valve may be attributed to host tissue overgrowth.This finding is generally considered a patient-related condition.

Manufacturer Narrative

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.

• 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: 3929295
• MDR Text Key: 4599121
• Report Number: 2025587-2014-00463
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2018
• Device Model Number: 305C225
• Device Catalogue Number: 305C225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2013
• 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: 00028 YR
• Patient Weight: 58