MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-04-08 for CRYOVALVE SG - PULMONARY VALVE & CONDUIT SGPV00 manufactured by Cryolife, Inc..
[4324048]
According to the phone call received from (b)(6), a pulmonary valve was implanted on (b)(6) 2014. During the implantation a portion of the valve was snipped and sent for a culture. Preliminary results indicate that it is growing a fungal organism of some type, but it does not appear to be aspergillus. The patient was admitted to the hospital on (b)(6) 2014, but the rehospitalization does not appear to be related to the implantation of the valve. The patient was hospitalized for a postoperative infection of the sternum wound and was discharged on (b)(6) 2014. The infection is not fungal in nature.
Patient Sequence No: 1, Text Type: D, B5
[11906064]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[35326839]
According to the phone call received from (b)(6), a synergraft pulmonary valve was implanted on (b)(6) 2014. During the implantation a portion of the valve was snipped and sent for a culture. Preliminary results indicate that it is growing a fungal organism of some type, but it does not appear to be aspergillus. The patient was admitted to the hospital on (b)(6) 2014, but the rehospitalization does not appear to be related to the implantation of the valve. The patient was hospitalized for a postoperative infection of the sternum wound and was discharged on (b)(6) 2014. The infection is not fungal in nature. Additional information was received which indicated the patient was initially hospitalized for a postoperative infection of sterum wound. The patient was discharged home and it did not appear to be linked to the valve implantation. The infection was not fungal in nature. Operative notes were provided which indicated preoperative and postoperative diagnoses of status post truncus arteriosus repair and conduit failure with stenosis and regurgitation. The procedure was a right ventricle to pulmonary artery conduit change using size 19mm cryopreserved pulmonary synergraft and pulmonary artery augmentation. Following receipt of this information, an additional contact attempt was made to obtain the final culture results. A reply was received which indicated the culture taken from the patient on (b)(6) 2014 grew staphylococcus aureus. Cryolife later received an email from the complainant which contained results of the culture from the (b)(6). The (b)(6) identified the species as non-sporulating basidiomycete. No information was received from the complainant to indicate why the results were reported as bacterial but the (b)(6) indicated results that were fungal. The case was investigated by performing a medical review, a formal donor review, manufacturing review, microbial and environmental review, quality review, and records review. The evidence obtained in this investigation convincingly establishes that the infection reported in this complaint was not allograft related. The absence of signs or symptoms of fungal infection in the donor effectively rules out the donor as a potential source of infection. All pre-implant cultures were negative for fungus; this effectively rules out processing contamination. The precise root cause of the reported event remains unknown; however, the evidence in this case points toward a hospital source.
Patient Sequence No: 1, Text Type: N, H10
[35326840]
According to the phone call received from (b)(6), a pulmonary valve was implanted on (b)(6) 2014. During the implantation a portion of the valve was snipped and sent for a culture. Preliminary results indicate that it is growing a fungal organism of some type, but it does not appear to be aspergillus. The patient was admitted to the hospital on (b)(6) 2014, but the rehospitalization does not appear to be related to the implantation of the valve. The patient was hospitalized for a postoperative infection of the sternum wound and was discharged on (b)(6) 2014. The infection is not fungal in nature.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2014-00014 |
| MDR Report Key | 3734767 |
| Report Source | 05,06 |
| Date Received | 2014-04-08 |
| Date of Report | 2014-03-31 |
| Date of Event | 2014-03-27 |
| Date Mfgr Received | 2014-03-31 |
| Date Added to Maude | 2014-04-09 |
| 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 - PULMONARY VALVE & CONDUIT |
| Generic Name | HEART VALVE ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2014-04-08 |
| Model Number | SGPV00 |
| Lot Number | 9970621 |
| ID Number | DONOR: 117853 |
| Device Expiration Date | 2017-04-30 |
| Operator | PHYSICIAN |
| 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. Hospitalization; 2. Other | 2014-04-08 |