MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-06-29 for CARDIOMEMS ENDOSURE DELIVERY SYSTEM ADS-1001 manufactured by Cardiomems, Inc..
[634495]
During the case, there was significant blood loss around the sensor tether and main body of the stent graft (approximately 900cc). This may have triggered a vagal response as the blood pressure dropped from 130 to 80. The patient received 1. 5 units of blood and fluids on the table. The patient was stable at the end of the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2007-00007 |
| MDR Report Key | 874184 |
| Report Source | 07 |
| Date Received | 2007-06-18 |
| Date of Report | 2007-06-15 |
| Date of Event | 2007-06-07 |
| Date Mfgr Received | 2007-06-08 |
| Date Added to Maude | 2007-07-06 |
| 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 Street | 75 FIFTH ST., NW SUITE 440 |
| Manufacturer City | ATLANTA GA 30308 |
| Manufacturer Country | US |
| Manufacturer Postal | 30308 |
| Manufacturer Phone | 4049206719 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOMEMS ENDOSURE DELIVERY SYSTEM |
| Generic Name | INTRAVASCULAR PRESSURE SENSOR |
| Product Code | NQH |
| Date Received | 2007-06-29 |
| Catalog Number | ADS-1001 |
| 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 | 854706 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | ATLANTA GA 30308 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-06-18 |