MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-08-15 for PULMONARY VALVE & CONDUIT SG SGPV00 manufactured by Cryolife, Inc. ? Kennesaw.
[117131784]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[117131785]
According to an email on 07/16/2018: "please acknowledge/confirm receipt of the below product size 26 that had been reported during a case/implant on friday (b)(6). I will be onsite later today/tomorrow to get more info. " an email was received on 07/17/2018 containing a form. The form states: cracks in tissue-muscle at base. Surgeons trimmed off muscle to get rid of cracks, leaving a narrow sewing margin to sew to. Patient impact is prolonged surgery. A phone call was made on 07/19/2018 to request when the cracks were noted, if the ifu's (instructions for use) were properly followed, and current patient status. The informant replied, "cracks were noted after the tissue was thawed, the ifu's were properly followed, and the patient is recovering from the procedure. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2018-00033 |
| MDR Report Key | 7784201 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-08-15 |
| Date of Report | 2018-10-11 |
| Date of Event | 2018-07-13 |
| Date Facility Aware | 2018-07-16 |
| Date Mfgr Received | 2018-07-16 |
| Date Added to Maude | 2018-08-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 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 | PULMONARY VALVE & CONDUIT SG |
| Generic Name | HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT |
| Product Code | OHA |
| Date Received | 2018-08-15 |
| Model Number | SGPV00 |
| Catalog Number | SGPV00 |
| Lot Number | 125641 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. ? KENNESAW |
| Manufacturer Address | 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2018-08-15 |