MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-08-13 for CARDIOMEMS ENDOSURE DELIVERY SYSTEM ADS-1001 manufactured by Cardiomems, Inc..
[16717317]
A standard aaa procedure with cardiomems endosure sensor was performed in 2007. Nothing unusual was reported during the case related to the sensor delivery. The next month, the pt returned for a 30 day follow up abdominal x-ray. It was noted that the aaa was stable and that there was tapered object resembling the shape of a delivery system nosecone inside the stent graft at the level of the celiac artery. Twenty-seven days later, the pt was admitted to the er for back pain. It was determined that there was blood in the aaa sac. The family asked that no additional surgery be performed. The pt expired the next day. An autopsy was performed and it was determined that there was a rough bone spur protruding anteriorly from the l4 vertebral body that lined up with the hole in the aortic sac. The autopsy also confirmed that the object inside the stent graft was the delivery system nosecone but that there was no penetration of the stent graft by the delivery system tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2007-00010 |
| MDR Report Key | 898079 |
| Report Source | 07 |
| Date Received | 2007-08-13 |
| Date of Report | 2007-08-13 |
| Date of Event | 2007-06-06 |
| Date Mfgr Received | 2007-08-03 |
| Date Added to Maude | 2007-11-28 |
| 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 | CARDIOMEMS ENDOSURE DELIVERY SYSTEM |
| Generic Name | INTRAVASCULAR PRESSURE SENSOR |
| Product Code | NQH |
| Date Received | 2007-08-13 |
| 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 | 924439 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | ATLANTA GA 30313 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-13 |