MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-23 for COR-KNOT 031350 manufactured by Lsi Solutions Inc..
[100782788]
Patient Sequence No: 1, Text Type: N, H10
[100782789]
During aortic valve replacement, the cor-knot misfired and the metal divet securing the valve in place did not deploy. The surgeon had to place another valve suture in and manually tie it in. This extended the surgical case time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7291636 |
| MDR Report Key | 7291636 |
| Date Received | 2018-02-23 |
| Date of Report | 2018-02-16 |
| Date of Event | 2018-02-13 |
| Report Date | 2018-02-16 |
| Date Reported to FDA | 2018-02-16 |
| Date Reported to Mfgr | 2018-02-16 |
| Date Added to Maude | 2018-02-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COR-KNOT |
| Generic Name | SUTURE, NONABSORBABLE, SYNTHETIC, POLYESTER |
| Product Code | GAS |
| Date Received | 2018-02-23 |
| Returned To Mfg | 2018-02-15 |
| Model Number | 031350 |
| Lot Number | 692165 |
| Device Expiration Date | 2019-09-30 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LSI SOLUTIONS INC. |
| Manufacturer Address | 7796 VICTOR-MENDON ROAD VICTOR NY 14564 US 14564 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-23 |