MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-02-02 for CARDIOMEMS ENDOSURE DELIVERY SYSTEM * ADS-1001 manufactured by Cardiomems, Inc..
[581712]
Patient had a large aneurysm neck and tortuous arteries and physician had difficulty in implanting the stent graft. The sensor was deployed. When the sensor delivery system was withdrawn, the dilator/hypotube caught on the stent graft. The physician removed the sensor delivery system, however, the main body of the stent graft deployed prematurely necessitating additional stent graft components to complete the procedure. The patient was converted to an aui with femoral-femoral bypass. The patient was discharged without further incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2007-00001 |
| MDR Report Key | 813009 |
| Report Source | 07 |
| Date Received | 2007-02-02 |
| Date of Report | 2007-02-02 |
| Date of Event | 2007-01-22 |
| Date Mfgr Received | 2007-01-22 |
| Date Added to Maude | 2007-02-08 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 75 FIFTH ST, NW STE 440 |
| Manufacturer City | ATLANTA GA 30308 |
| Manufacturer Country | US |
| Manufacturer Postal | 30308 |
| Manufacturer Phone | 4049206712 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2007-02-02 |
| Model Number | * |
| Catalog Number | ADS-1001 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 800493 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | * ATLANTA GA 30308 US |
| Baseline Brand Name | ENDOSURE AAA PRESSURE SENSOR/DELIVERY SYSTEM |
| Baseline Generic Name | INTRASAC PRESSURE SENSOR/DELIVERY CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | ADS-1001 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-02-02 |