POLYFLEX STENT M00570330 7033

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number6000146-2007-00013
MDR Report Key853594
Report Source03
Date Received2007-05-22
Date of Report2007-04-25
Date Mfgr Received2007-04-25
Date Added to Maude2007-09-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactKEN HIRAKAWA
Manufacturer Street100 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086836264
Manufacturer G1RUSCH GMBH GERMANY/TELEFLEX MEDICAL
Manufacturer Street2345 WAUKEGAN ROAD
Manufacturer CityBANNOCKBURN IL 60015
Manufacturer CountryUS
Manufacturer Postal Code60015
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePOLYFLEX STENT
Product CodeNYT
Date Received2007-05-22
Model NumberM00570330
Catalog Number7033
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key883656
ManufacturerRUSCH GMBH GERMANY/TELEFLEX MEDICAL
Manufacturer AddressBANNOCKBURN IL 60015 US


Patients

Patient NumberTreatmentOutcomeDate
111. Required No Informationntervention 2007-05-22

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