FDA Adverse Event Malfunction Summary report: N

SUPERA PERIPHERAL STENT SYSTEM

MDR report key: 3908295 · Received June 27, 2014

Report

Report Number
3908295
Event Type
Malfunction
Date Received
June 27, 2014
Date of Event
June 11, 2014
Report Date
June 27, 2014
Manufacturer
IDEV TECHNOLOGIES, INC.
Product Code
NIP
Product Problem
Yes
Report Source
User Facility report
Reporter Location
AZ, US

Narratives

Description of Event or Problem · 1

DURING THE PROCEDURE, THE PHYSICIAN NOTED RESIDUAL DISSECTION DISTALLY COVERING THE ADDUCTOR CANAL, HE ADVANCED A 4.5 X 120-MM SUPERA SELF-EXPANDING STENT DUE TO ITS HIGH TENSILE STRENGTH AND LOW RISK OF STENT FRACTURE. THE STENT WAS DEPLOYED UNDER FLUOROSCOPY, AND JUST PRIOR TO THE STENT BEING RELEASED FROM THE DELIVERY SYSTEM, THE PROXIMAL NOSE OF THE DELIVERY SHEATH BROKE OFF AND WAS RETAINED IN THE STENT ITSELF. THE LAST 10 MM OF THE SUPERA STENT WERE UN-DEPLOYED IN THE VESSEL AND PARTIALLY DEPLOYED IN THE SHEATH. AT THIS TIME, THE PHYSICIAN TRIED TO ADVANCE A SMALL 1.5 EMERGE BALLOON. THIS WOULD NOT ADVANCE DUE TO THE UN-DEPLOYED NATURE OF THE STENT IN THE SHEATH. HE WENT IN WITH A LASSO SNARE SYSTEM INITIALLY AND THE LASSO WAS USED TO RETRACT THE DETACHED CONE OF THE SHEATH SUCCESSFULLY. HE THEN WENT IN WITH A 7.0 X 200-MM MUSTANG BALLOON, WHICH WAS GOING TO BE USED FOR POST-STENT DILATATION ANYWAY, AND ONCE THIS WAS ADVANCED INTO THE DISTAL PART OF THE SHEATH, THE REMAINING PORTION OF THE SUPERA STENT SELF-DEPLOYED SUCCESSFULLY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
376773 SUPERA PERIPHERAL STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY NIP IDEV TECHNOLOGIES, INC. * 02217055

Patients

Seq Age Sex Outcome Treatment
1 63 YR