MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-04-22 for ENDOSURE S2 PRESSURE MEASUREMENT SYSTEM S2-2080 manufactured by Cardiomems, Inc..
[1156062]
The patient presented with small iliac arteries with calcification. The sensor was implanted without an issue. The stent graft was deployed which resulted in relocation of the sensor to the right iliac artery. Since the location of the sensor had changed from the original, optimal location, the surgeon decided to remove the sensor and stent graft sheath. Upon removal of both the sensor and stent graft sheath, a damaged portion of the iliac artery was also removed. The surgeon repaired the iliac artery and aneurysm without incident. The patient recovered from the aneurysm surgery and was discharged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2009-00001 |
| MDR Report Key | 1368453 |
| Report Source | 07 |
| Date Received | 2009-04-22 |
| Date of Report | 2009-04-17 |
| Date of Event | 2009-03-23 |
| Date Mfgr Received | 2009-03-26 |
| Date Added to Maude | 2011-03-21 |
| 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 | 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 | ENDOSURE S2 PRESSURE MEASUREMENT SYSTEM |
| Generic Name | INTRAVASCULAR PRESSURE SENSOR |
| Product Code | NQH |
| Date Received | 2009-04-22 |
| Catalog Number | S2-2080 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | ATLANTA GA 30313 US 30313 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-04-22 |