MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-07-02 for CRYOVALVE SG- PULMONARY VALVE AND CONDUIT SGPV00 manufactured by Cryolife, Inc..
[21725981]
(b)(6), cvor coordinator of (b)(6) hospital, stated that on (b)(6) 2014, they had a pulmonary valve fracture. It had to be explanted and it was kept for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[22086683]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[30252868]
Cryolife representative stated that he received a voicemail stating that the hospital had a pulmonary valve fracture and it was kept for evaluation. The synergraft pulmonary valve and conduit was received in a cup with enough solution as to be completely submerged. The valve was transected at the bifurcation. A 0. 8cm tear was located in the muscle band, 2. 3cm from the transection at the bifurcation, and extended into the left semilunar cusp (lsc). Three cracks were observed in the internal muscle band, one of which extended from the anterior/right (ar) post to the left/right (lr) post. Another crack was observed in the conduit. It was also noted that there were no signs that the allograft had been implanted. There were no sutures, no holes left by suturing, and no remnants of patient blood. The damage observed is consistent with damage caused by mishandling the allograft while in the frozen state. It is likely that the damage occurred at the user facility; cryolife personnel are trained to properly handle cryopreserved allografts and no errors or deficiencies were found in the processing record reviews. The instructions for use states, "cryopreserved allografts are fragile and must be handled with care while in the frozen state to avoid causing damage to the allograft" and "cardiac allografts are human biological tissues and, as such present considerable anatomical variation. Specific allograft attributes (representing normal variation) and donor-specific information is described in the allograft diagram and the certificate of assurance supplied with each allograft. "
Patient Sequence No: 1, Text Type: N, H10
[30252869]
(b)(6), cvor coordinator of (b)(6), stated that on (b)(6) 2014 they had a pulmonary valve fracture it was kept for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2014-00026 |
| MDR Report Key | 3910206 |
| Report Source | 06 |
| Date Received | 2014-07-02 |
| Date of Report | 2014-06-24 |
| Date of Event | 2014-06-23 |
| Date Mfgr Received | 2014-06-24 |
| Date Added to Maude | 2014-07-02 |
| 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 AND CONDUIT |
| Generic Name | HEART VALVE ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2014-07-02 |
| Returned To Mfg | 2014-07-01 |
| Model Number | SGPV00 |
| Lot Number | 10372214 |
| ID Number | DONOR NUMBER: 128086 |
| Device Availability | R |
| 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 | 2014-07-02 |