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 2017-03-03 for CRYOVALVE SG PULMONARY VALVE AND CONDUIT SGPV00 manufactured by Cryolife, Inc..
[68976553]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[68976554]
"razor thin posterior muscle cuff that had a tear or v-shaped defect that extended down to within a mm or so of hinge point of valve cusp. We reconstituted the muscle cuff there and it worked out, although post-repair echo showed mild pi. Muscle was sort of pale also - different shade or color than i'm used to. Anyway, patient is fine, all is well. Just thought you should know. Have a great time away. " via doctor. (b)(6). Patient impact was listed as prolonged surgery.
Patient Sequence No: 1, Text Type: D, B5
[75232645]
According to the doctor? S notes received via email on (b)(6) 2017: "razor thin posterior muscle cuff that had a tear or v-shaped defect that extended down to within an mm or so of hinge point of valve cusp. We reconstituted the muscle cuff there and it worked out, although post-repair echo showed mild pi. Muscle was sort of pale also - different shade or color than i'm used to. Anyway, patient is fine, all is well. Just thought you should know.?? A review of training records indicates that the technician who inspected this allograft was appropriately trained for the task she performed. The inspector noted: one 6mm unrepaired tear in the muscle band 3mm from the lsc (left semilunar cusp) annulus. A donor review was also performed. According to the processing records, this allograft did not contain any attributes that would have rejected the allograft. Graft 10949532 was not returned to cryolife so no direct observations could be made. Pictures were provided from the hospital.? It is possible that the tear could have torn closer than 3mm with handling and pulling of the muscle band by the surgeon, as seen in pictures provided. The certificate of assurance was reviewed. All attributes identified? Were documented appropriately. An acceptable tear was noted in that location, that met specifications. The root cause of the event is unknown; however, based on the information available the issue may have occurred while manipulating the tissue during the procedure as shown in the pictures provided.
Patient Sequence No: 1, Text Type: N, H10
[75232646]
"razor thin posterior muscle cuff that had a tear or v-shaped defect that extended down to within a mm or so of hinge point of valve cusp. We reconstituted the muscle cuff there and it worked out, although post-repair echo showed mild pi. Muscle was sort of pale also - different shade or color than i'm used to. Anyway, patient is fine, all is well. Just thought you should know. Have a great time away. " via doctor. Sid is (b)(6). Patient impact was listed as prolonged surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2017-00010 |
| MDR Report Key | 6375721 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-03-03 |
| Date of Report | 2017-05-05 |
| Date of Event | 2017-02-07 |
| Date Facility Aware | 2017-02-07 |
| Date Mfgr Received | 2017-02-07 |
| Device Manufacturer Date | 2016-12-04 |
| Date Added to Maude | 2017-03-03 |
| 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 | 2017-03-03 |
| Model Number | SGPV00 |
| Lot Number | 142199 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-03-03 |