MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-09-19 for CARDIOMEMS ENDOSURE SENSOR S2-2080 manufactured by Cardiomems, Inc..
[956119]
The physician inadvertently delivered the sensor above the deployed main body of the stent graft. Multiple attempts were unsuccessfully made to bring the sensor back down through the main body of the stent graft into the aneurysm sac. The physician decided to release the sensor in the aorta above the aneurysm/stent graft and snare it when the placement of the stent graft was complete. The stent graft was placed without issues and an attempt was made to snare the sensor. During the attempt, the sensor was not captured and was inadvertently moved to the lower thoracic aorta. Additional attempts to snare the sensor were made. It was decided by the physician to leave the sensor in the lower thoracic aorta. The physicians will follow the location of the sensor on x-ray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2008-00006 |
| MDR Report Key | 1164104 |
| Report Source | 07 |
| Date Received | 2008-09-19 |
| Date of Report | 2008-09-05 |
| Date of Event | 2008-09-03 |
| Date Mfgr Received | 2008-09-03 |
| Date Added to Maude | 2008-09-19 |
| 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 | MRS. GRACE POWERS |
| Manufacturer Street | 387 TECHNOLOGY CIRCLE NW SUITE 500 |
| Manufacturer City | ATLANTA GA 30313 |
| Manufacturer Country | US |
| Manufacturer Postal | 30313 |
| Manufacturer Phone | 6786512300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOMEMS ENDOSURE SENSOR |
| Generic Name | IMPLANTABLE INTRA-ANEURYSM PRESSURE MEASUREMENT SYSTEM |
| Product Code | NQH |
| Date Received | 2008-09-19 |
| Catalog Number | S2-2080 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1187699 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | 387 TECHNOLOGY CIRCLE NW SUITE 500 ATLANTA GA 30313 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-09-19 |