MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-08-01 for CRYOVALVE SG - PULMONARY HEMI-ARTERY SG SGPH00 manufactured by Cryolife, Inc..
[4890398]
The surgeon scheduled operation for (b)(6) for hypoplastic aortic arch repair/vsd closure. Surgeon chose a 45mm synergraft pulmonary hemi-artery to be used for the aortic arch repair. Staff and surgeon inspected packaging and thawed the homograft. Upon thawing and removing from pouch, it was discovered that the tissue was an aortic valve instead of the indicated pulmonary hemi-artery. Surgeon made the decision to use the aortic valve, resulting in a successful aortic arch repair. Surgeon indicated prolonged procedure time as well as homograft tissue being thicker than desired for the repair he was performing. There was no report of actual patient injury.
Patient Sequence No: 1, Text Type: D, B5
[11942087]
There was no allegation of actual patient injury in abundance of caution we are reporting this as an adverse event based on the allegation of a prolonged surgery. Based the inclusion of the aortic valve, which was not intended for commercial distribution, rather than the labeled pulmonary hemiartery in the package, we are also reporting this event as a "malfunction". This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[37121768]
The surgeon scheduled operation for (b)(6) for hypoplastic aortic arch repair/vsd closure. Surgeon chose a 45mm synergraft pulmonary hemi-artery to be used for the aortic arch repair. Staff and surgeon inspected packaging and thawed the homograft. Upon thawing and removing from pouch, it was discovered that the tissue was an aortic valve instead of the indicated pulmonary hemi-artery. Surgeon made the decision to use the aortic valve, resulting in a successful aortic arch repair. Surgeon indicated prolonged procedure time as well as homograft tissue being thicker than desired for the repair he was performing. There was no report of actual patient injury. There was no allegation of actual patient injury in abundance of caution we are reporting this as an adverse event based on the allegation of a prolonged surgery. Based the inclusion of the aortic valve, which was not intended for commercial distribution, rather than the labeled pulmonary hemiartery in the package, we are also reporting this event as a "malfunction. " the root cause for this complaint was related to the mislabeling of the allograft during the packaging process in the tissue processing laboratory. A corrective action has occurred to ensure only one allograft label is printed at a time prior to final packaging which would only allow one labeled sid card to be present during a packaging session. Also the procedure has been revised to require a member of the supervisory staff to perform the label verification prior to cryopreservation.
Patient Sequence No: 1, Text Type: N, H10
[37121769]
The surgeon scheduled operation for (b)(6) for hypoplastic aortic arch repair/vsd closure. Surgeon chose a 45mm synergraft pulmonary hemi-artery to be used for the aortic arch repair. Staff and surgeon inspected packaging and thawed the homograft. Upon thawing and removing from pouch, it was discovered that the tissue was an aortic valve instead of the indicated pulmonary hemi-artery. Surgeon made the decision to use the aortic valve, resulting in a successful aortic arch repair. Surgeon indicated prolonged procedure time as well as homograft tissue being thicker than desired for the repair he was performing. There was no report of actual patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2014-00028 |
| MDR Report Key | 3973804 |
| Report Source | 06,07 |
| Date Received | 2014-08-01 |
| Date of Report | 2014-07-03 |
| Date of Event | 2014-07-03 |
| Date Mfgr Received | 2014-07-03 |
| Date Added to Maude | 2014-08-01 |
| 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 | 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 HEMI-ARTERY SG |
| Generic Name | HEART ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2014-08-01 |
| Model Number | SGPH00 |
| ID Number | DONOR NUMBER: 127638 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-08-01 |