MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-03-01 for CRYOVALVE SG PULMONARY VALVE AND CONDUIT SGPV00 manufactured by Cryolife, Inc..
[68752054]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[68752075]
"pulmonary valve with conduit (sgpv00)? 29 mm x 5. 0 cm? Serial id # (b)(4), exp. Date: september 10, 2020, sized and measured @26 mm? (using a hegar dilator). Instead of the stated size 29 mm" pulmonary valve was saved and will be returned. Surgery was prolonged as a synthetic graft was used instead. The pulmonary valve (sid (b)(4)) was returned in a sample return specimen cup provided by (b)(6) hospital, containing saline. Tissue size tested with a size 26 mm dilator that provided a clear view into the conduit and was determined to be too small for the valve. A 29 mm dilator was used on the final size test and was determined to be an appropriate size for the valve. Upon further examination, the 26 mm dilator was used to inspect the size of tissue conduit and provided an accurate measure. No damage was noted and tissue texture was smooth.
Patient Sequence No: 1, Text Type: D, B5
[73857638]
The sample was evaluated on 02/10/2017. The tissue size was tested with a size 26mm hegar dilator that provided a clear view past the basal ring into the conduit and was determined to be too small. A 29mm hegar dilator was used on the final test and was determined to be an appropriate size for the tissue at the basal ring, where tissue measurements are taken. Upon further examination, the 26mm hegar dilator was used to inspect the size of the tissue conduit and provided an accurate measure. No damage was noted and tissue texture was smooth. Root cause for alleged event is unknown; however, the investigation suggests a difference in sizing technique. The inspector was certified to size cardiac tissues prior to performing inspection on 8/03/2015 and following inspection on 01/07/2016. The certificate of assurance was reviewed. All attributes identified? Were documented appropriately, including the graft size. It was confirmed that the dilators documented at inspection correlate to the graft size and all were within calibration at the time of inspection. While a definitive root cause is unknown, the size discrepancy noted by the complainant may be due to the difference in sizing technique. Information regarding the surgeon? S method is unknown. This event does not identify additional hazards or modify the probability and severity of existing hazards.
Patient Sequence No: 1, Text Type: N, H10
[73857639]
"pulmonary valve with conduit (sgpv00)? 29mm x 5. 0 cm? Serial id #(b)(4) exp. Date: september 10, 2020 sized and measured @26 mm? (using a hegar dilator). Instead of the stated size 29 mm," pulmonary valve was saved and will be returned. Surgery was prolonged as a synthetic graft was used instead. The pulmonary valve (sid 10763267) was returned in a sample return specimen cup provided by (b)(4), containing saline. Tissue size tested with a size 26mm dilator that provided a clear view into the conduit and was determined to be too small for the valve. A 29mm dilator was used on the final size test and was determined to be an appropriate size for the valve. Upon further examination, the 26mm dilator was used to inspect the size of tissue conduit and provided an accurate measure. No damage was noted and tissue texture was smooth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2017-00009 |
| MDR Report Key | 6368217 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-03-01 |
| Date of Report | 2017-04-13 |
| Date of Event | 2017-02-01 |
| Date Facility Aware | 2017-02-02 |
| Date Mfgr Received | 2017-02-02 |
| Device Manufacturer Date | 2015-06-21 |
| Date Added to Maude | 2017-03-01 |
| 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 | ROCHELLE MANEY |
| Manufacturer Street | 1655 ROBERTS BLVD. NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| 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 AND CONDUIT |
| Generic Name | HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2017-03-01 |
| Returned To Mfg | 2017-02-06 |
| Model Number | SGPV00 |
| Lot Number | 134231 |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2017-03-01 |