DYNAMIC Y STENT M00570680

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-12-03 for DYNAMIC Y STENT M00570680 manufactured by Boston Scientific - Marlborough.

Event Text Entries

[3002635] Note: this report pertains to one of two devices used during the same procedure. Manufacturer report # 3005099803-2012-05629 and 3005099803-2012-05630 address these devices. It was reported to boston scientific corporation that two dynamic y stents were attempted to be placed during a pulmonary procedure performed on (b)(6) 2012. According to the complainant, the indication for the stent placement was treatment for a malignant occlusion at the distal trachea up to the voice box. During the procedure, the physician could not get the stent (3005099803-2012-05629) down, due to the occlusion and tortuous anatomy. A second dynamic y stent (3005099803-2012-05630) was obtained, when trying to place the second stent, the physician released the forceps which caused the stent to drop and obstruct the patients airway. The patient's stats starting dropping due to the airway being blocked by the stent, an emergency tracheotomy was immediately performed. There were no attempts made to remove the stent prior to performing the tracheotomy due to drop in the patent's stats. The stent was removed after the tracheotomy was performed. The patient was put on a ventilator for 4-5 days and then another dynamic y stent was successfully placed through tracheotomy site. The physician indicated that it was very difficult to place a stent, due to the patient anatomy (tumor location) and edema that occurred because of multiple attempts to place a stent. The edema was not treated and left to resolve on its own. The patient's condition was reported to be stable post procedure.
Patient Sequence No: 1, Text Type: D, B5


[10263623] (b)(4) for the reported event of positioning/placement issue. The complainant indicated that the device was disposed of, therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005099803-2012-05630
MDR Report Key2855055
Report Source05,07
Date Received2012-12-03
Date of Report2012-11-08
Date of Event2012-11-08
Date Mfgr Received2012-11-08
Device Manufacturer Date2012-10-04
Date Added to Maude2012-12-03
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 ContactEMP. CHARLES MONTGOMERY
Manufacturer Street100 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834000
Manufacturer G1WILLY RUESCH GMBH
Manufacturer StreetWILLY RUESCH STRASSE 4-10
Manufacturer CityKERNEN 71394
Manufacturer Postal Code71394
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDYNAMIC Y STENT
Generic NamePROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC
Product CodeNYT
Date Received2012-12-03
Model NumberM00570680
Lot Number0000012381
Device Expiration Date2017-08-31
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC - MARLBOROUGH
Manufacturer Address100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-12-03

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