MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2006-09-12 for POLYFLEX ESOPHAGEAL STENT * 1433 manufactured by Rusch Gmbh Germany/teleflex Medical.
[622309]
The complainant has reported that a female pt underwent a therapeutic placement of a stent for treatment of a refractory stricture in her distal esophagus. The initial device was placed in 2006 (unk facility/unk clinician). Some time after the initial placement, the stent was noted to have migrated to the pt's stomach. The clinician attempted to retrieve the initial stent without success (please note associated medwatch 6000146-2006-00007 attached). The clinician then placed this polyflex stent which also migrated to the pt stomach. The pt stricture status was unchanged. The clinician has indicated that the devices are not able to be removed endoscopically. It is unk, if the pt has had subsequent surgical intervention to remove the migrated devices. There is no further info available at this time. Requests for an update to the pt status have not been provided at time of this submission.
Patient Sequence No: 1, Text Type: D, B5
[7911026]
This device has not been received by this mfr. An eval has not yet been performed. Therefore, a failure analysis is not available and we are unable to determine if the device met its specs. Should further relevant details become available; a supplemental medwatch report will be filed under the appropriate sequence number. We are unable to determine the relationship between this device and the cause for this event at this time. Our directions for use outline appropriate placement, access and maintenance procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000146-2006-00008 |
| MDR Report Key | 880342 |
| Report Source | 05,06,07 |
| Date Received | 2006-09-12 |
| Date of Report | 2006-08-29 |
| Date of Event | 2006-08-29 |
| Date Mfgr Received | 2006-08-29 |
| Date Added to Maude | 2007-07-16 |
| 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 | 3 |
| Manufacturer Contact | KEN HIRAKAWA |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE |
| Manufacturer City | NATICK MA 01760 |
| Manufacturer Country | US |
| Manufacturer Postal | 01760 |
| Manufacturer Phone | 5086836264 |
| Manufacturer G1 | RUSCH GMBH GERMANY/TELEFLEX MEDICAL |
| Manufacturer Street | 2345 WAUKEGAN RD |
| Manufacturer City | BANNOCKBURN IL 60015 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60015 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYFLEX ESOPHAGEAL STENT |
| Generic Name | ESOPHAGEAL PROSTHESIS |
| Product Code | EJW |
| Date Received | 2006-09-12 |
| Model Number | * |
| Catalog Number | 1433 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 859322 |
| Manufacturer | RUSCH GMBH GERMANY/TELEFLEX MEDICAL |
| Manufacturer Address | 2345 WAUKEGAN ROAD BANNOCKBURN IL 60015 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-12 |