FDA Adverse Event Injury Summary report: N

EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM

MDR report key: 1051066 · Received May 22, 2008

Report

Report Number
2134265-2008-01484
Event Type
Injury
Date Received
May 22, 2008
Date of Event
April 24, 2008
Report Date
April 25, 2008
Manufacturer
BOSTON SCIENTIFIC
Product Code
FGE
PMA / PMN Number
K021630
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A FEMORAL STENTING PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE 48 % STENOTIC LESION WAS LOCATED IN THE FEMORAL ARTERY. ACCESS WAS OBTAINED VIA THE FEMORAL APPROACH WITH A 19 GAUGE ENTRY NEEDLE. A .035" GUIDE WIRE WAS INSERTED THROUGH THE NEEDLE AND THE NEEDLE WAS REMOVED OVER THE GUIDE WIRE. A 5F INTRODUCER SHEATH WAS THEN PLACED OVER THE GUIDE WIRE, AND THE GUIDE WIRE WAS REMOVED. ANOTHER MFR'S CATHETER WAS ADVANCED TO THE RIGHT ILIAC ARTERY, AND A SELECTIVE ANGIOGRAM OF THE RIGHT ILIAC, COMMON FEMORAL, AND PROXIMAL PROFUNDA WAS PERFORMED. ALL THREE VESSELS APPEARED TO BE PATENT. A .035" NON-BSC GUIDE WIRE WAS PLACED IN THE CATHETER AND THE CATHETER WAS REMOVED. ANOTHER MFR'S 5MM CATHETER WAS ADVANCED TO THE TIBIO-PERONEAL TRUNK FOR DILATATION; IT WAS INFLATED TWICE, TO 7 AND 8 ATMS, RESPECTIVELY. THE BALLOON WAS THEN PULLED BACK TO THE DISTAL POPLITEAL ARTERY AND INFLATED TWICE, TO 4 AND 8 ATMS, RESPECTIVELY. THE BALLOON WAS THEN PULLED BACK TO THE DISTAL SUPERFICIAL FEMORAL ARTERY AND INFLATED ONCE TO 8 ATMS. THE GUIDE WIRE WAS REMOVED AND A SELECTIVE ANGIOGRAM OF THE BALLOONED SEGMENTS REVEALED SIGNIFICANT IMPROVEMENT IN THE TIBIO-PERONEAL TRUNK. MODERATE IMPROVEMENT WAS OBSERVED IN THE DISTAL SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES WITH SOME RESIDUAL STENOSIS. A 7MM X 37MM EXPRESS LD STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH THE SHEATH TO THE LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. THE STENT BECAME "DISENGAGED FROM THE BALLOON" PRIOR TO INFLATION, AND EMBOLIZED TO THE POPLITEAL ARTERY. ATTEMPTS WERE MADE TO RETRIEVE THE STENT; HOWEVER, THEY WERE UNSUCCESSFUL. THE STENT WAS "PARKED" IN THE DISTAL POPLITEAL ARTERY AT THE AREA OF THE RESIDUAL STENOSIS. SELECTIVE ANGIOGRAMS WERE PERFORMED FOR THE STENTED SEGMENT AND THE MID SUPERFICIAL FEMORAL ARTERY SHOWED IMPROVED FLOW AND MILD RESIDUAL NARROWING. THE PROCEDURE WAS ABORTED AT THIS POINT. NO FURTHER PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS IS LISTED AS "GOOD".

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC NA 11511733

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention CONTRA2 CATHETER| 6F DESTINATION SHEATH| 55MM ADMIRAL BALLOON,| .035" GLIDEWIRE.