FDA Adverse Event Malfunction Summary report: N

WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

MDR report key: 1011366 · Received March 11, 2008

Report

Report Number
2134265-2008-00732
Event Type
Malfunction
Date Received
March 11, 2008
Date of Event
February 13, 2008
Report Date
February 13, 2008
Manufacturer
BOSTON SCIENTIFIC
Product Code
FGE
PMA / PMN Number
K993232
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
JA
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, THE WALLSTENT COULD NOT BE RETRIEVED. THE 80% STENOSED AND CALCIFIED LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS LEFT ANTEBRACHIUM. THE PHYSICIAN HAD BEGUN TO DEPLOY THE WALLSTENT, AND APPROX HALF OF THE STENT HAD BEEN DEPLOYED, SOMEWHERE BETWEEN THE DISTAL MARKER AND THE LIMIT MARKER. THE PHYSICIAN TRIED TO RECONSTRAIN THE STENT FOR REPOSITIONING, HOWEVER, HE WAS UNABLE TO RECONSTRAIN THE STENT. THE STENT DELIVERY SYSTEM WAS THEN RETRIEVED INTO THE INTRODUCER SHEATH AND REMOVED WITHOUT FURTHER INCIDENT. THE PT DID NOT EXPERIENCE ANY SYMPTOMS DURING THIS EVENT. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER OF THE SAME DEVICES, AND PT STATUS WAS REPORTED AS 'GOOD'. THE PHYSICIAN AGAIN TRIED TO RECONSTRAIN THE WALLSTENT INTO THE OUTER SHEATH ONCE IT WAS OUTSIDE OF THE BODY AND IT WAS COMPLETED 'SMOOTHLY'. THE STENT WAS DEPLOYED SUCCESSFULLY OUTSIDE THE BODY. THE PHYSICIAN ATTRIBUTED THE DIFFICULTIES IN RECONSTRAINING THE STENT TO ANATOMY ISSUES (CALCIFICATION).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC NA 11196079

Patients

Seq Age Sex Outcome Treatment
1 GUIDEWIRE: RADIFOCUS| BALLOON CATHETER: SYNERGY| INTRODUCER SHEATH: MOSQUITO 6F| INFLATION DEVICE: MEDTRONIC