MAUDE Adverse Event Report: HEART VALVES SANTA ANA MOSAIC AORTIC BIOPROSTHETIC HEART VALVE; TIMER, CLOT, AUTOMATED

Model Number 305

Device Problem Insufficient Information (3190)

Patient Problems Corneal Pannus (1447); Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758)

Event Date 07/20/2017

Event Type  Injury  

Manufacturer Narrative

Without the return 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 approximately 10 years post implant of this aortic bioprosthetic valve, it was replaced with a non medtronic device, due to increased severity of tissue valve stenosis.No additional adverse patient effects were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the valve was distorted; oval shaped with deflected stent posts.Small needle holes in the sewing ring showed placement of implantation sutures.The sewing ring was damaged all around exposing the stent.All leaflets were in the closed position with wavy free margins.All leaflets were flexible except on the areas where pannus was observed along the margin of the attachments of all leaflets (inflow).The right cusp exhibited tan thrombotic host tissue and calcification nodules on the inflow and outflow.The non-coronary right commissure was covered with pannus.The condition of the tissue of the commissure could not be assessed.The left right commissure exhibited small tears of the left and right leaflets.The non-coronary left was intact with small amount of pannus above the superior coaptive area.White pannus lined the inflow margin of attachments adjacent to all cusps extending into all inferior coaptive areas, and extending 1 to 5 mm onto all cusps showing a possible reduced inflow orifice area.Traces of pannus was observed on all outflow rails.A large piece of pannus was embedded with the sutures along the sewing cloth adjacent to the non-coronary cusp.Tan thrombotic host tissue filled and stiffened the right cusp.An unknown amount of pannus appeared to have been removed on the inflow and outflow during explant.Nodules of calcification were observed on the inflow and outflow of the right cusp.Radiography confirmed calcification at the right cusp and at the left right commissure.Patient weight added.Implant date added.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: TIMER, CLOT, AUTOMATED
• 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: 6793727
• MDR Text Key: 82668469
• Report Number: 2025587-2017-01387
• Device Sequence Number: 1
• Product Code: GKN
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2011
• Device Model Number: 305
• Device Catalogue Number: 30521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/20/2006
• 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: 78 YR
• Patient Weight: 69