MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2007-08-20 for D-STAT FLOWABLE HEMOSTAT 4000 manufactured by Vascular Solutions, Inc..
[19262529]
D-stat flowable was used as an adjunct to hemostasis during a pulse generator replacement procedure in an anticoagulated patient. The patient returned to the coumadin clinic approximately one week post procedure with a inr of 4. 4. The patient's coumadin level was reduced and the inr rechecked three days later. No clot was detected, so coumadin was withheld. Subsequent rechecks continued to show elevated inr levels. The patient was admitted to the hospital where vitamin k therapy was initiated. Coagulation testing completed at that time showed normal fibrinogen, slightly elevated thrombin time. Factor 2,5,7 and 10 activity levels were also evaluated, and it was noted that the factor 5 level was 2% (of normal). These results suggest the development of a factor v deficiency. As of this writing, the condition of the patient is not known.
Patient Sequence No: 1, Text Type: D, B5
[19327152]
The development of factor v deficiency following exposure to bovine-derived thrombin products is a recognized extremely rare complication documented in the clinical literature and in the warning section of the d-stat flowable instructions for use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134812-2007-00019 |
| MDR Report Key | 898830 |
| Report Source | 05,06,07 |
| Date Received | 2007-08-20 |
| Date of Report | 2007-08-17 |
| Date of Event | 2007-06-29 |
| Date Mfgr Received | 2007-07-19 |
| Device Manufacturer Date | 2007-05-01 |
| Date Added to Maude | 2007-08-23 |
| 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 | JAMES CHAPMAN |
| Manufacturer Street | 6464 SYCAMORE COURT |
| Manufacturer City | MINNEAPOLIS MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| Manufacturer Phone | 7636564380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | D-STAT FLOWABLE HEMOSTAT |
| Generic Name | TOPICAL HEMOSTAT |
| Product Code | MHW |
| Date Received | 2007-08-20 |
| Model Number | 4000 |
| Lot Number | 540650 |
| Device Expiration Date | 2007-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 876385 |
| Manufacturer | VASCULAR SOLUTIONS, INC. |
| Manufacturer Address | MINNEAPOLIS MN 55369 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2007-08-20 |