POLYFLEX ESOPHAGEAL STENT * 1430

MAUDE Adverse Event Report

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 * 1430 manufactured by Rusch Gmbh Germany/teleflex Medical.

Event Text Entries

[17071871] 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 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. The clinician placed another polyflex stent which also migrated to the pt stomach (please note associated medwatch 6000146-2006-00008 attached). 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


[17231901] 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


MAUDE Entry Details

Report Number6000146-2006-00007
MDR Report Key880340
Report Source05,06,07
Date Received2006-09-12
Date of Report2006-08-29
Date of Event2006-08-29
Date Mfgr Received2006-08-29
Date Added to Maude2007-07-16
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 FDA3
Event Location3
Manufacturer ContactKEN HIRAKAWA
Manufacturer StreetONE BOSTON SCIENTIFIC PLACE
Manufacturer CityNATICK MA 01760
Manufacturer CountryUS
Manufacturer Postal01760
Manufacturer Phone5086836264
Manufacturer G1RUSCH GMBH GERMANY/TELEFLEX MEDICAL
Manufacturer Street2345 WAUKEGAN RD
Manufacturer CityBANNOCKBURN IL 60015
Manufacturer CountryUS
Manufacturer Postal Code60015
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePOLYFLEX ESOPHAGEAL STENT
Generic NameESOPHAGEAL PROSTHESIS
Product CodeEJW
Date Received2006-09-12
Model Number*
Catalog Number1430
Lot NumberUNK
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagY
Date Removed*
Device Sequence No1
Device Event Key859307
ManufacturerRUSCH GMBH GERMANY/TELEFLEX MEDICAL
Manufacturer Address2345 WAUKEGAN RD BANNOCKBURN IL 60015 US


Patients

Patient NumberTreatmentOutcomeDate
10 2006-09-12

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