MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-28 for CARPENTIER-EDWARDS 25 MM NA manufactured by Baxter Healthcare, Cvs Division.
[18552875]
Patient developed endocarditis, which was diagnosed 5 mo. Post implantation. He had unsuccessful treatment with antibiotics and was referred for operative valve replacement due to recurrent symptoms & persistent vegetations. Aortic valve endocarditis. Implant in may 1993. Received in formalin "bovine aortic valve implant and aorta" are three fragments of tissue and material. The first is consistent with bovine aortic valve and has overall dimensions of 3. 5 x 3. 6 x up to 1. 4 cm. The specimen is composed of tan mesh and wire and valvular tissue. The valvular tissue appears relatively intact with three distinct leaflets noted. Covering two of the leaflets and approximately 60% of the valvular surface area is tan/red fibrinous material. This portion of the specimen is represented in a. Also within the specimen container are two separate fragments of tissue, the largest measuring up to 3. 2 cm and the smaller measuring up to 1. 5 cm. Grossly this portion of the specimen is consistent with aorta. Sectioning reveals that the tissue is firm with possible calcific areas. Representative cross sections are submitted in b.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16754 |
| MDR Report Key | 16754 |
| Date Received | 1994-08-28 |
| Date of Report | 1994-02-01 |
| Date of Event | 1993-12-21 |
| Date Facility Aware | 1993-12-21 |
| Report Date | 1994-02-01 |
| Date Reported to Mfgr | 1994-02-01 |
| Date Added to Maude | 1994-10-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARPENTIER-EDWARDS |
| Generic Name | BIOPROSTHETIC AORTIC VALVE |
| Product Code | MIM |
| Date Received | 1994-08-28 |
| Model Number | 25 MM |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | EXP DATE 11/95 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 7 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 16687 |
| Manufacturer | BAXTER HEALTHCARE, CVS DIVISION |
| Manufacturer Address | 17221 RED HILL AVE. IRVINE CA 92714 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-08-28 |