MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-09-14 for CARDIOMEMS ENDOSURE DELIVERY SYSTEM S2-2080 manufactured by Cardiomems, Inc..
[708404]
The patient had very calcified and tortuous iliac's. The sensor and main body of stent graft were placed in the patient, but not deployed. While these were in place a left renal artery stent was placed from brachial access. This turned out to be a lengthy step in the procedure and during this time, there was much bleeding from the valve of the sheath with the sensor and main body of the stent graft. After the sensor and main body of the stent graft were deployed the bleeding improved, but blood had to be given to the patient. The case was completed without any issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2007-00014 |
| MDR Report Key | 933057 |
| Report Source | 07 |
| Date Received | 2007-09-14 |
| Date of Report | 2007-09-13 |
| Date of Event | 2007-09-05 |
| Date Mfgr Received | 2007-09-07 |
| Date Added to Maude | 2007-12-18 |
| 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 | 6786512323 |
| 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 | 2007-09-14 |
| Catalog Number | S2-2080 |
| 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 | 930049 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | ATLANTA GA 30313 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-09-14 |