POLYFLEX AIRWAY STENT M00570130 7013

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06 report with the FDA on 2009-11-06 for POLYFLEX AIRWAY STENT M00570130 7013 manufactured by Boston Scientific Corporation.

Event Text Entries

[20831442] Exact implant and explant dates are unk. The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant info is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


[20841881] Note: this report is one of six complaints filed for this event. Refer to manufacturer report # 3005099803-2009-05259, 3005099803-2009-05260, 3005099803-2009-05262, 3005099803-2009-05263, and 3005099803-2009-05264 for the other associated device info. It was reported to boston scientific corp (bsc) on oct 7, 2009, that 6 polyflex airway stents were used during 6 esophageal stenting procedures performed on a male. According to the complainant, the pt had suffered from esophageal atresia since birth. The pt had undergone frequent repeated esophageal dilatations in hopes of removing his feeding tube. The attending physician was researching other options. She consulted with another physician regarding his temporary stenting technique. The physician was made aware by bsc that this was an off-indication technique. After throughly researching the use of stents, consulting with her team of surgeons, and receiving the consent of the pt's family, the physician decided to proceed with the treatment. Beginning in 2009, a series of 6 polyflex airway stents were placed consecutively in the pt's esophagus. Each of the first five stents were placed, left in place for approx 2 weeks, and then removed without issue. The treatment was successful with the pt able to progress to the oral intake of food. The physician stated that the first five stents were unrelated to the event. The final stent was placed the following month. The following month, the pt was admitted to the hosp emergency room with esophageal bleeding. It was discovered that the pt had a congenital malformation of blood vessels which had ruptured due to pressure of the stent. The stent was removed without issue and the bleeding was stopped. A few days later, the pt expired. According to the physician, the cause of death was the congenital malformation of blood vessels that ruptured due to pressure of the final stent. This condition was unk at the time of placement and was only discovered when the pt presented with esophageal bleeding. An autopsy was performed. Bsc requested autopsy results and was informed that results would not be released. Although the physician stated that the first five stents placed were unrelated to the event, without the definitive cause of death from the autopsy results, bsc has decided to conservatively file medwatch reports on all six stent complaints associated with this event. Bsc will continue to pursue further clarification of this event. If add'l info is obtained, a supplemental mdr will be submitted to the fda. This report is for the third stent placed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2009-05261
MDR Report Key1525042
Report Source00,01,05,06
Date Received2009-11-06
Date of Report2009-10-07
Date of Event2009-08-28
Date Mfgr Received2009-10-07
Device Manufacturer Date2009-05-01
Date Added to Maude2009-11-12
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 Location0
Manufacturer ContactCHARLES MONTGOMERY
Manufacturer Street100 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086836132
Manufacturer G1WILLY RUESCH GMBH
Manufacturer StreetWILLY RUESCH STRASSE 4-10
Manufacturer CityKERNEN, DE 71394
Manufacturer CountryGM
Manufacturer Postal Code71394
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePOLYFLEX AIRWAY STENT
Product CodeNYT
Date Received2009-11-06
Model NumberM00570130
Catalog Number7013
Lot Number0000009201
Device Expiration Date2014-04-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressMARLBOROUGH MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Death; 2. Hospitalization; 3. Required No Informationntervention 2009-11-06

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