MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-07-09 for CARDIOMEMS ENDOSURE DELIVERY SYSTEM S2-2080 manufactured by Cardiomems, Inc..
[3139655]
The sensor was placed in the aaa after the main body of the stent graft was deployed. The sensor would not release easily from the delivery system and was pulled down lower than the optimal position above the stent graft contralateral limb gate. As the contralateral limb was inserted the sensor was pushed inside of the main body of the stent graft. The physician was unable to remove the sensor at this point and an additional aortic cuff had to be placed inside the main body of the stent graft to trap the sensor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2007-00008 |
| MDR Report Key | 2971423 |
| Report Source | 07 |
| Date Received | 2007-07-09 |
| Date of Report | 2007-07-09 |
| Date of Event | 2007-06-22 |
| Date Mfgr Received | 2007-06-29 |
| Date Added to Maude | 2013-02-25 |
| 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 |
| 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 | 2007-07-09 |
| Catalog Number | S2-2080 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | ATLANTA GA 30308 US 30308 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-07-09 |