MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-10-22 for CRYOVALVE SG - SG PULMONARY VALVE AND CONDUIT SG SGPV00 manufactured by Cryolife, Inc..
[22137757]
According to the report, the pre-implant culture was positive for staphylococcus epidermidis. Laboratory contamination (at the hospital) cannot be ruled out; laboratory reagent was positive for staphylococcus epidermidis and staphylococcus warneri. The allograft was implanted on (b)(6) 2014 and the patient has been discharged. There has been no indication of an adverse reaction in the patient.
Patient Sequence No: 1, Text Type: D, B5
[22279689]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[23682221]
According to the report, the pre-implant culture was positive for staphylococcus epidermidis. Laboratory contamination cannot be ruled out; laboratory reagent was positive for staphylococcus epidermidis and staphylococcus warneri. The allograft was implanted on (b)(6) 2014 and the patient has been discharged. There has been no indication of an adverse reaction in the patient. Cryolife has reviewed the information available concerning the allograft associated with this reported event. In addition, a review of the processing, environmental, quality, and donor records has been performed. The evidence obtained in this investigation convincingly establishes that the organism obtained via pre-implant sterility culture was not allograft related. No infection or adverse patient impact was associated with this complaint; the source of staphylococcus epidermidis in the pre-implant culture was most likely the laboratory testing reagent, which was found to be contaminated with staphylococcus epidermidis. Additionally, results from microbiological testing of the allograft that were taken during processing and packaging were negative for staphylococcus epidermidis. There is no indication that an error or deficiency occurred at cryolife.
Patient Sequence No: 1, Text Type: N, H10
[23682222]
According to the report, the pre-implant culture was positive for staphylococcus epidermidis. Laboratory contamination (at the hospital) cannot be ruled out; laboratory reagent was positive for staphylococcus epidermidis and staphylococcus warneri. The allograft was implanted on (b)(6) 2014 and the patient has been discharged. There has been no indication of an adverse reaction in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2014-00047 |
| MDR Report Key | 4194680 |
| Report Source | 01,05,06 |
| Date Received | 2014-10-22 |
| Date of Report | 2014-10-16 |
| Date of Event | 2014-10-16 |
| Date Mfgr Received | 2014-10-16 |
| Device Manufacturer Date | 2014-01-14 |
| Date Added to Maude | 2014-10-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA O'REILLY |
| Manufacturer Street | 1655 ROBERTS BLVD., NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD., NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOVALVE SG - SG PULMONARY VALVE AND CONDUIT SG |
| Generic Name | HEART VALVE, ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2014-10-22 |
| Model Number | SGPV00 |
| Device Expiration Date | 2019-01-14 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | 1655 ROBERTS BLVD., NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-22 |