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 M50070200 7020 manufactured by Rusch Gmbh Germany/teleflex Medical.
[21712168]
Note: the date of event is unk. 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 # 6 - record 1 of 2. Seven days after a polyflex stent placement in the trachea of a male patient, the "stent migrated". The stent was replaced with another polyflex stent which migrated three days later, and was replaced with a unk t-tube. The patient was "doing well with 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
[21799171]
The lot number of the device used is unk; consequently, the manufacture date of the device is unk. 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. Please note associated medwatch report 6000146-2007-00022.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000146-2007-00021 |
| MDR Report Key | 853628 |
| Report Source | 03 |
| Date Received | 2007-05-22 |
| Date of Report | 2007-04-25 |
| Date Mfgr Received | 2007-04-25 |
| Date Added to Maude | 2007-06-11 |
| 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 | M50070200 |
| Catalog Number | 7020 |
| Lot Number | UNK |
| 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 | 845391 |
| Manufacturer | RUSCH GMBH GERMANY/TELEFLEX MEDICAL |
| Manufacturer Address | BANNOCKBURN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-05-22 |