EXPRESS LD OTW 7.0 MM X 57 CM
Received May 20, 2022 · Event occurred May 9, 2022
Report MW5109826 · MDR key 14470969
Device
Product problems
- Break
- Entrapment of Device
Patient
63 YR · Male
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
SEVERE PAD WITH RETAINED UNDEPLOYED STENT FOUND IN THE LEFT CFA DURING LLE ANGIOGRAPHY AND ATTEMPTED RETRIEVAL OF RETAINED STENT. UNDER ULTRASOUND GUIDANCE THE RIGHT CFA WAS ACCESSED WITH A MICROPUNCTURE NEEDLE AND THE MICRO PUNCTURE SHEATH WAS EXCHANGED FOR A 5 FRENCH SHEATH. FEMORAL ANGIOGRAPHY WAS PERFORMED. A 5 FRENCH OMNI FLUSH CATHETER WAS THEN ADVANCED INTO THE DISTAL ABDOMINAL AORTA AND A GLIDE WIRE ADVANTAGE WAS USED TO ACCESS THE CONTRALATERAL LIMB. OF NOTE THERE WAS A 9 MM PRESSURE GRADIENT ACROSS THE RIGHT ILIAC SYSTEM AND A 60 MM PRESSURE GRADIENT ACROSS THE LEFT EXTERNAL ILIAC. AT THIS POINT IT BECAME APPARENT THAT THERE WAS A RETAINED UNDEPLOYED STENT IN THE LEFT CFA WHICH CLEARLY HAD COME OFF OF THE BALLOON DURING THE PRIOR PROCEDURE WHEN EVERYTHING WAS PULLED OUT. EXCHANGED THE 5 FRENCH SHEATH FOR A 7 FRENCH DESTINATION SHEATH AND PATIENT WAS ANTICOAGULATED WITH UNFRACTIONATED HEPARIN WITH ACT MONITOR TO MAINTAIN GOAL GREATER THAN 250. A 0.018 COMMAND ST WIRE WAS ADVANCED THROUGH THE STENT HOWEVER DISTALLY I WAS CLEARLY IN THE SUBINTIMAL SPACE AND WAS NOT ABLE TO ACCESS THE TRUE LUMEN. TRANSITIONED TO AN APPROACH OF TRYING TO SNARE THE STENT AND ULTIMATELY WAS ABLE TO SUCCESSFULLY SNARE THE PROXIMAL PORTION OF THE STENT HOWEVER DESPITE HAVING A GOOD GRIP THE STENT WAS VERY FIRMLY LODGED IN THE WALL OF THE ARTERY AND THEREFORE THE DECISION WAS MADE TO ABORT FURTHER ATTEMPTS AT REMOVAL AND TRANSFER THE PATIENT FOR CFA ENDARTERECTOMY IN ORDER TO RETAIN THE STENT AND ALSO STENT THE LEFT ILIAC ARTERY. PATIENT TRANSFERRED TO ANOTHER HOSPITAL FOR VASCULAR SURGERY CONSULT. FDA SAFETY REPORT ID # (B)(4).