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

Model Number 305C

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 11/07/2016

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested, but no new information has been received to date.The device has not been received for analysis.Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation.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.

Event Description

Medtronic received information that seventeen days post implant of this aortic bioprosthetic valve, it was explanted and replaced due to stenosis, central regurgitation, and increased gradients.Echocardiogram revealed peak gradients measuring 50mmhg.The etiology of the valvular disease was reported as a congenital abnormality and bicuspid calcification.No other adverse patient effects were reported.

Manufacturer Narrative

Analysis: the product was received in a clear 0.2% glutaraldehyde solution in an explant kit.A visual examination of the device was performed upon receipt.The valve appeared distorted, oval shaped, with one of the stent posts significantly bent inward.All leaflets were slightly stiff but flexible.All leaflets appeared intact.All leaflets were in the closed position with a gap between the coaptive ridge of the left cusp and the other two cusps.All commissures were intact.Traces of pannus were observed along the inflow and outflow tracts.A thin layer of pannus was noted on the top of the right non-coronary stent post.An unknown amount of pannus appeared to have been removed on the inflow and outflow.Radiography showed no evidence of mineralization in the valve.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.Conclusion: based on the received information and the returned product analysis, the valve distortion could have caused the leaflets to be immobile, leading to stenosis and elevated gradients across the valve.This distortion appeared to be consistent with a sizing issue and/or squeezing the stent during implant.Also, distortion of the annular ring and bent stent post can restrict the leaflets from fully opening and cause misalignment of leaflets during valve closure, which may have led to regurgitation.

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: 6227842
• MDR Text Key: 64009191
• Report Number: 2025587-2017-00035
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2017

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: 03/28/2021
• Device Model Number: 305C
• Device Catalogue Number: 305C223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2016
• Initial Date FDA Received: 01/05/2017
• Supplement Dates Manufacturer Received: Not provided; 03/29/2017
• Supplement Dates FDA Received: 03/31/2017; 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2016
• 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: 57 YR