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 M00570200 7020 manufactured by Rusch Gmbh Germany/teleflex Medical.
[16502924]
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 6000146-2007-00021.
Patient Sequence No: 1, Text Type: N, H10
[16706522]
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 2 of 2. Three days after a second polyflex stent placement in the trachea of a male patient, the "stent migrated". The stent 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
Report Number | 6000146-2007-00022 |
MDR Report Key | 853627 |
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 | M00570200 |
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 | 845372 |
Manufacturer | RUSCH GMBH GERMANY/TELEFLEX MEDICAL |
Manufacturer Address | BANNOCKBURN IL US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 1 | 1. Required No Informationntervention | 2007-05-22 |