MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2006-04-03 for SMART CONTROL NITINOL STENT SYSTEM * C08080SJ manufactured by Cordis De Mexico.
[15697341]
During a percutaneous transluminal angioplasty to the right external iliac artery, there was resistance and premature deployment of the stent. There were no anomalies noted during product inspection or when prepping device following the instruction for use. The target vessel was moderately calcified, with heavy tortuousity and had 95% stenosis present. The lesion was predilated. There was large resistance when approaching the target site. Physician increased force to insert the stent delivery system while approaching the target lesion. At this moment, the stent, was prematurely released short of the target lesion however was retrieved without any complications. Another stent was used to end procedure successfully. There was no pt injury. This product will be returned for evaluation and testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616099-2006-00355 |
| MDR Report Key | 697018 |
| Report Source | 01,05,07 |
| Date Received | 2006-04-03 |
| Date of Report | 2006-04-03 |
| Date of Event | 2006-03-13 |
| Date Mfgr Received | 2006-03-13 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2006-04-10 |
| 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 | DR. THOMAS MORRISSEY, MED. DIRECTOR |
| Manufacturer Street | 14201 NW 60TH AVENUE |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal | 33014 |
| Manufacturer Phone | 7863132516 |
| Manufacturer G1 | CORDIS DE MEXICO |
| Manufacturer Street | PARQUE INDUSTRIAL SALVADOR |
| Manufacturer City | JUAREZ, CHIHUAHUA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMART CONTROL NITINOL STENT SYSTEM |
| Generic Name | SELF EXPANDING STENTS |
| Product Code | FGF |
| Date Received | 2006-04-03 |
| Model Number | * |
| Catalog Number | C08080SJ |
| Lot Number | A0905634 |
| ID Number | PART#: NA |
| Device Expiration Date | 2007-09-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 686127 |
| Manufacturer | CORDIS DE MEXICO |
| Manufacturer Address | * JUAREZ, CHIHUAHUA MX |
| Baseline Brand Name | SMART CONTROL NITINOL STENT SYSTEM |
| Baseline Generic Name | SELF EXPANDING STENTS |
| Baseline Model No | * |
| Baseline Catalog No | C08080SJ |
| Baseline ID | PART#: NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-04-03 |