ST-2 SOEHENDRA TANNENBAUM BILIARY STENT

MDR report key: 15094958 · Received July 25, 2022

Report

Report Number: 3005580113-2022-00076
Event Type: Injury
Date Received: July 25, 2022
Date of Event: April 1, 2000
Report Date: July 25, 2022
Manufacturer: COOK IRELAND LTD
Product Code: FGE
Adverse Event: Yes
Product Problem: Yes
Report Source: Distributor report
Reporter Location: MS, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

MEDICAL PRODUCTS: FGE CATHETER, BILIARY, DIAGNOSTIC.

Description of Event or Problem · 0

AMANN 2000, A WIRE-LOOP TECHNIQUE FOR REMOVAL OF MIGRATED AND EMBEDDED BILIARY STENTS. FOUR WEEKS EARLIER SHE HAD TWO 8.5F, 15 CM, STRAIGHT, BARBED, ENDOPROSTHESES (SOEHENDRA-TANNENBAUM STENT; WILSON-COOK MEDICAL INC., (B)(4)) PLACED INTO HER BILIARY SYSTEM TO TREAT BILIARY TRACT OBSTRUCTION. THESE STENTS HAD BEEN PLACED IN THE RIGHT AND LEFT DUCTAL SYSTEMS WITH PROPER PLACEMENT CONFIRMED ENDOSCOPICALLY AND FLUOROSCOPICALLY. HER LIVER FUNCTION TESTS HAD RETURNED TO NORMAL EXCEPT FOR MILD ELEVATION OF ALKALINE PHOSPHATASE. AT PRESENTATION SHE HAD NO JAUNDICE BUT HAD COMPLAINTS OF FEVERS, DARK URINE, AND MILD RIGHT UPPER QUADRANT PAIN. AT ERCP THE PREVIOUSLY PLACED STENTS WERE EMBEDDED INTO THE CONTRALATERAL DUODENAL WALL, WITH INFLAMMATION AND ULCERATION IN THE MUCOSA SURROUNDING THE STENTS. THE FLANGES ON THE EXTRADUCTAL PORTIONS WERE BURIED IN THE DUODENAL MUCOSA. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE STENTS USING A STANDARD ENDOSCOPIC OVAL SNARE (SENSATION SNARE, MICROVASIVE). IN ADDITION, ATTEMPTS TO PUSH OR PULL THE STENT OUT OF THE MUCOSA WITH A RAT-TOOTH GRASPING FORCEPS (OLYMPUS) WERE UNSUCCESSFUL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
968109	ST-2 SOEHENDRA TANNENBAUM BILIARY STENT		FGE	COOK IRELAND LTD		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR	Female	Required Intervention