MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number 24653

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 08/23/2019

Event Type  Injury  

Event Description

It was reported that during removal, the tip of the delivery system became stuck on the implanted stent and surgical intervention was required to remove it.The 90% stenosed target lesion was located in the severely calcified and moderately tortuous right superficial femoral artery (sfa).A non-bsc introducer sheath was inserted from the left femoral.The.035 non-bsc guidewire was inserted from the right sfa and the introducer sheath was advanced to the other side.A.014 non-bsc guidewire and a non-bsc micro-catheter were advanced to the lesion and crossed.The physician attempted to cross the lesion with ivus, but it caught on the calcification and had difficulty crossing.The physician attempted pre-dilatation, but the non-bsc balloon catheter did not cross.A 2mm x 4cm coyote balloon catheter was used to pre-dilate the lesion.After that, a non-bsc balloon catheter was used for pre-dilatation as well.The physician tried to advance ivus again, but it was unable to cross.Dilatation was performed with a non-bsc balloon catheter.Angiography was performed and a slight indentation was observed in the contrast findings.Dilatation was performed again with the previous non-bsc balloon catheter.Ivus was passed through and confirmed the lesion area.The findings showed circumferential severe calcification in the mid part of some lesions, but the lumen had expanded to about 3mm.The angiography confirmed dilatation, so it was decided to place the stent.A non-bsc angiographic diagnostic catheter was advanced up the.014 non-bsc guidewire, then the guidewire was changed to a.035 non-bsc guidewire.A 6x120x130 eluvia self-expanding stent was then unpacked and advanced to the lesion.The stent was placed successfully on the lesion.When retrieving the delivery system, the tip of the delivery system got caught on the placed stent near the mid-lesion in the right sfa.In an attempt to release the delivery system, the physician pulled the delivery system further and it seemed to be stuck.It was impossible to push or pull the delivery system.They attempted to return the middle sheath to its original location and upon trying to release the tip, a puncture needle was inserted in the hole on the handle.The thumb wheel was then turned in the reverse direction to try to return the middle sheath to the pre-deployment state, but there was no change in the stuck state.The delivery system's shaft was cut, and the handle, outer shaft, and middle shaft were removed.Only the tip and the inner shaft remained in the introducer sheath.A.014 non-bsc guidewire was passed next to the stuck tip in the stent and a non-bsc balloon catheter was advanced.They attempted to release the stuck piece by expanding the balloon.The guidewire did not pass through the part where the tip was stuck, and this method was difficult.A non-bsc guide extension catheter was advanced to the part just before the stuck tip, and the tip part was pushed and pulled.This did not resolve the issue.A snare catheter was inserted, and delivery was attempted.Due to the severe resistance in the introducer sheath, the delivery was difficult, and this method was abandoned.The tip was successfully removed by surgical intervention in the operating room.The surgeon cut the skin and exposed the vessel around the lesion.The physician compressed the vessel slightly under fluoroscopy and released the stuck tip.The tip removal was complete, and nothing was left in the patient.There were no additional patient complications.The patient was recovering post procedure.

Event Description

It was reported that during removal, the tip of the delivery system became stuck on the implanted stent and surgical intervention was required to remove it.The 90% stenosed target lesion was located in the severely calcified and moderately tortuous right superficial femoral artery (sfa).A non-bsc introducer sheath was inserted from the left femoral.The.035 non-bsc guidewire was inserted from the right sfa and the introducer sheath was advanced to the other side.A.014 non-bsc guidewire and a non-bsc micro-catheter were advanced to the lesion and crossed.The physician attempted to cross the lesion with ivus, but it caught on the calcification and had difficulty crossing.The physician attempted pre-dilatation, but the non-bsc balloon catheter did not cross.A 2mm x 4cm coyote balloon catheter was used to pre-dilate the lesion.After that, a non-bsc balloon catheter was used for pre-dilatation as well.The physician tried to advance ivus again, but it was unable to cross.Dilatation was performed with a non-bsc balloon catheter.Angiography was performed and a slight indentation was observed in the contrast findings.Dilatation was performed again with the previous non-bsc balloon catheter.Ivus was passed through and confirmed the lesion area.The findings showed circumferential severe calcification in the mid part of some lesions, but the lumen had expanded to about 3mm.The angiography confirmed dilatation, so it was decided to place the stent.A non-bsc angiographic diagnostic catheter was advanced up the.014 non-bsc guidewire, then the guidewire was changed to a.035 non-bsc guidewire.A 6x120x130 eluvia self-expanding stent was then unpacked and advanced to the lesion.The stent was placed successfully on the lesion.When retrieving the delivery system, the tip of the delivery system got caught on the placed stent near the mid-lesion in the right sfa.In an attempt to release the delivery system, the physician pulled the delivery system further and it seemed to be stuck.It was impossible to push or pull the delivery system.They attempted to return the middle sheath to its original location and upon trying to release the tip, a puncture needle was inserted in the hole on the handle.The thumbwheel was then turned in the reverse direction to try to return the middle sheath to the pre-deployment state, but there was no change in the stuck state.The delivery system's shaft was cut, and the handle, outer shaft, and middle shaft were removed.Only the tip and the inner shaft remained in the introducer sheath.A.014 non-bsc guidewire was passed next to the stuck tip in the stent and a non-bsc balloon catheter was advanced.They attempted to release the stuck piece by expanding the balloon.The guidewire did not pass through the part where the tip was stuck, and this method was difficult.A non-bsc guide extension catheter was advanced to the part just before the stuck tip, and the tip part was pushed and pulled.This did not resolve the issue.A snare catheter was inserted, and delivery was attempted.Due to the severe resistance in the introducer sheath, the delivery was difficult, and this method was abandoned.The tip was successfully removed by surgical intervention in the operating room.The surgeon cut the skin and exposed the vessel around the lesion.The physician compressed the vessel slightly under fluoroscopy and released the stuck tip.The tip removal was complete, and nothing was left in the patient.There were no additional patient complications.The patient was recovering post procedure.

Manufacturer Narrative

Device evaluation by mfr: returned product consisted of an eluvia self-expanding stent system stuck on a 0.035" guidewire.The inner liner and tip of the device were checked for damage.Visual examination revealed that the inner liner was separated 104.8cm from the tip of the device.There was buckling to the inner liner 72.2cm from the tip.Microscopic examination revealed scratch marks all over the tip of the device.The proximal section of the device was missing and did not return for product analysis.The missing parts are the handle with its components, the outer sheath, middle sheath, proximal inner, and the proximal section of the separated inner liner.The guidewire was measured and was approximately 300cm long.Product analysis confirmed the difficulty to remove the device from the wire.The tip of the device was located approximately 13.5cm from the distal end of the guidewire.Inspection of the remainder of the device, revealed no other damage or irregularities.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9030693
• MDR Text Key: 158162091
• Report Number: 2134265-2019-11153
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2020
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023219153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Manufacturer Received: 08/24/2019
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: 09/20/2019
• Supplement Dates FDA Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: .014 COMMAND, ASTATOGUIDEWIRE; .014 COMMAND, ASTATOGUIDEWIRE; .035 RADIFOCUS GUIDEWIRE; .035 RADIFOCUS GUIDEWIRE; COYOTE ES OTW 2MM4CMBALLOON CATHETER; COYOTE ES OTW 2MM4CMBALLOON CATHETER; CXI 2.6 FRMICRO-CATHETER; CXI 2.6 FRMICRO-CATHETER; GOODTECH CATHETER 5FR JR (NIPRO); GOODTECH CATHETER 5FR JR (NIPRO); MOUNT FUJI IIINFLATION DEVICE; MOUNT FUJI IIINFLATION DEVICE; PARENT PLUS 6FR. 45CM INTRODUCER SHEATH; PARENT PLUS 6FR. 45CM INTRODUCER SHEATH; .014 COMMAND, ASTATOGUIDEWIRE; .035 RADIFOCUS GUIDEWIRE; COYOTE ES OTW 2MM4CMBALLOON CATHETER; CXI 2.6 FRMICRO-CATHETER; GOODTECH CATHETER 5FR JR (NIPRO); MOUNT FUJI IIINFLATION DEVICE; PARENT PLUS 6FR. 45CM INTRODUCER SHEATH
• Patient Outcome(s): Required Intervention