MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-08-15 for MOSAIC AORTIC BIOPROSTHETIC HEART VALVE 305 30521 manufactured by Heart Valves Santa Ana.
[82668469]
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.
Patient Sequence No: 1, Text Type: N, H10
[82668470]
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.
Patient Sequence No: 1, Text Type: D, B5
[98478363]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[100163103]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2025587-2017-01387 |
| MDR Report Key | 6793727 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-15 |
| Date of Report | 2017-11-02 |
| Date of Event | 2017-07-20 |
| Date Mfgr Received | 2017-11-01 |
| Device Manufacturer Date | 2006-11-20 |
| Date Added to Maude | 2017-08-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | HEART VALVES SANTA ANA |
| Manufacturer Street | 1851 E DEERE AVE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92705 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOSAIC AORTIC BIOPROSTHETIC HEART VALVE |
| Generic Name | TIMER, CLOT, AUTOMATED |
| Product Code | GKN |
| Date Received | 2017-08-15 |
| Returned To Mfg | 2017-09-01 |
| Model Number | 305 |
| Catalog Number | 30521 |
| Device Expiration Date | 2011-11-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEART VALVES SANTA ANA |
| Manufacturer Address | 1851 E DEERE AVE SANTA ANA CA 92705 US 92705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-15 |