MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-05-11 for NEUROFORM2 TREO MICRODELIVERY STENT SYSTEM * S345015 manufactured by Boston Scientific Corp, Neurovascular Div.
[380057]
During an event the neuroform2 treo microdelivery stent system would not cross the lesion, and upon withdrawal of the system, the stent deployed. Left the stent implanted and stopped the procedure. The pt was reported to be doing good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000078-2005-00074 |
| MDR Report Key | 603460 |
| Report Source | 07 |
| Date Received | 2005-05-11 |
| Date of Report | 2005-05-10 |
| Date of Event | 2005-04-27 |
| Date Mfgr Received | 2005-04-27 |
| Device Manufacturer Date | 2004-04-01 |
| Date Added to Maude | 2005-05-19 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | ALEN KRIKORIAN |
| Manufacturer Street | 47900 BAYSIDE PKWY |
| Manufacturer City | FREMONT CA 945386515 |
| Manufacturer Country | US |
| Manufacturer Postal | 945386515 |
| Manufacturer Phone | 8006622415 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROFORM2 TREO MICRODELIVERY STENT SYSTEM |
| Generic Name | INTRAVASCULAR STENT |
| Product Code | HJE |
| Date Received | 2005-05-11 |
| Model Number | * |
| Catalog Number | S345015 |
| Lot Number | MAR04103U |
| ID Number | * |
| Device Expiration Date | 2006-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 593296 |
| Manufacturer | BOSTON SCIENTIFIC CORP, NEUROVASCULAR DIV |
| Manufacturer Address | * FREEMONT CA * US |
| Baseline Brand Name | NEUROFORM2 TREO MICRODELIVERY STENT SYSTEM |
| Baseline Generic Name | INTRAVASCULAR STENT |
| Baseline Model No | * |
| Baseline Catalog No | S345015 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-05-11 |