MAUDE Adverse Event Report: HEART VALVES SANTA ANA VALVE CONTEGRA; CONDUIT,VALVED,PULMONIC

Model Number CONTEGRA

Device Problems Calcified (1077); Insufficient Information (3190)

Patient Problems Corneal Pannus (1447); Calcium Deposits/Calcification (1758); No Information (3190)

Event Date 06/06/2017

Event Type  Injury  

Manufacturer Narrative

Additional information was requested from the physician's practice, including the patient demographic information, device information, and reason for explant, but the physician's practice was unable to provide more information.The device has been received for analysis and a supplemental report with the analysis results may be submitted after the analysis is complete.

Event Description

Medtronic received information that following implant of this bioprosthetic pulmonic valve (implant duration not indicated), this device was explanted and replaced due to calcification.No other adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the device arrived in pieces in an explant kit.There were two pieces of the valved conduit wall.Visible calcification and pannus were observed on the pieces.Blue monofilament was found sutured on conduit wall.The condition of all commissures could not be determined due to pannus and calcification.All leaflets or remnants of leaflet pieces were stiffened by pannus and calcification.Pannus was observed in all conduit pieces on the outer wall and inner lumen.Radiography revealed calcification in all the conduit pieces.Conclusion: based on the condition of the returned device, it appears that, the device has been implanted for some time that calcification and pannus have infiltrated the device.The reported event was confirmed by analysis, calcification was observed.Calcification is a known common cause of bioprosthesis failure.Many factors can contribute to the onset and propagation of calcification including patient related (e.G.Patient age, disease state, immune status, and other co-morbidities), pharmacological, and intrinsic properties of the valve itself.Pannus formation is patient dependent based on the possible underlying cause.There are many studies which discuss the etiology of pannus (excessive scar formation).Chronic pannus formation may be precipitated by an immune response to the bioprosthetic valve sewing ring and /or sutures and size of the bioprosthesis.It may also be caused by the presence of an injured endothelial surface potentially releasing fibroblast growth factor-2, blood flow turbulence, pregnancy and /or inadequate anti-coagulation.The time of pannus formation after valve implantation varies; studies have reported time frames from 6-12 months.The ingrowth of the tissue may gradually affect the function of the valve leaflets (1 ,2).(1) bassel al-alao et al., ¿rapid pannus formation after few months of obstructing aortic mechanical prosthesis,¿ gen thorac cardiovasc surg, september 25 2013, http://link.Springer.Com/article/10.1007%2fs11748-013-0319-0#page-1.(2) se jin oh et al., ¿reoperation for non-structural valvular dysfunction caused by pannus ingrowth in aortic valve prosthesis,¿ the journal of heart valve disease, vol.22, no.4, july 2013, pp.591 ¿ 598.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALVE CONTEGRA
• Type of Device: CONDUIT,VALVED,PULMONIC
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): HEART VALVES SANTA ANA; 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: 6682254
• MDR Text Key: 78897690
• Report Number: 2025587-2017-01071
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020003
• 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,Followup,Followup
• Report Date: 07/09/2017

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 Model Number: CONTEGRA
• Device Catalogue Number: CONTEGRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 07/09/2017; 07/09/2017
• Supplement Dates FDA Received: 07/24/2017; 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention