MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2007-05-22 for POLYFLEX STENT M00570330 7033 manufactured by Rusch Gmbh Germany/teleflex Medical.
[626255]
On april 25, 2007, a boston scientific corporation employee became aware of a clinical study article, "performance of a self-expanding silicone stent in palliation of benign airway conditions", published in chest (american college of chest physicians/chest 2006; 130;1419-1423). The study conducted was a retrospective review of the medical records of all patients in whom a polyflex stent was used to treat a symptomatic benign airway condition. The following information was derived from that article. Case #1 a male patient expectorated a large fragment of the distal inner lining of a polyflex stent 7 months after stent placement in the trachea. A follow-up bronchoscopy revealed a total loss of stent integrity. The polyflex stent was successfully removed and replaced with a t-tube. "all patients with stent-related complications had increased shortness of breath and cough". Several attempts have been made to obtain the patient's current status to no avail. "a ct scan of the chest aided the selection of a stent with an appropriate diameter. Stents were oversized by 1 to 2 mm compared to the desired lumen; the latter was based on the proximal extent of the abnormality. The length of the stent was based on a direct measurement of the obstructed segment using a flexible bronchoscope. Depending on the degree and type of the stenosis, dilation of the involved airway was performed either using a rigid bronchoscope (rb) or a balloon prior to the stent placement. Endobronchial electrosurgery was used to cut concentric-type, web-like stenosis, if indicated. All stents were placed via an rb or a suspension laryngoscope under general anesthesia and fluoroscopic guidance using a team approach. "
Patient Sequence No: 1, Text Type: D, B5
[7957565]
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. The april 2007 15-month polyflex airway stent complaint trend report, inclusive of all failure modes, was reviewed; no adverse trend was noted and no data point exceeded the complaint alert limit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000146-2007-00013 |
| MDR Report Key | 853594 |
| Report Source | 03 |
| Date Received | 2007-05-22 |
| Date of Report | 2007-04-25 |
| Date Mfgr Received | 2007-04-25 |
| Date Added to Maude | 2007-09-11 |
| 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 Contact | KEN HIRAKAWA |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086836264 |
| Manufacturer G1 | RUSCH GMBH GERMANY/TELEFLEX MEDICAL |
| Manufacturer Street | 2345 WAUKEGAN ROAD |
| 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 STENT |
| Product Code | NYT |
| Date Received | 2007-05-22 |
| Model Number | M00570330 |
| Catalog Number | 7033 |
| Lot Number | UNKNOWN |
| 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 | 883656 |
| Manufacturer | RUSCH GMBH GERMANY/TELEFLEX MEDICAL |
| Manufacturer Address | BANNOCKBURN IL 60015 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1 | 1. Required No Informationntervention | 2007-05-22 |