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

Model Number 24653

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/19/2019

Event Type  Injury  

Event Description

It was reported that the stent partially deployed, elongated and separated.A piece of the stent remained in the patient and another stent was placed over the fractured stent.The 100% stenosed target lesion was located in the severely calcified and severely tortuous superficial femoral artery (sfa).Contralateral approach was performed and even with the tortuous bifurcation, the non-bsc introducer sheath was able to pass without issue.A.035 non-bsc guidewire was used.The first eluvia device was placed at the distal sfa and the during deployment, the thumbwheel went in circles.The stent was successfully deployed using the pull grip.The second device, a 7 x 120 x 130 eluvia self expanding stent was then attempted to place with overlap.The thumbwheel was hard to turn and would not deploy the stent.The pull grip did not deploy the stent either.The physician attempted to pull out the stent and sheath together, but part of the stent was attached to the vessel wall.The stent stretched and was brought to the area around the iliac and separated about 3 cm at the tip of the bifurcation area.The physician attempted to recover it with a radial jaw, but that failed.The physician placed another stent where the fractured stent remained to prevent movement.There were no patient complications.Upon removal, the device looked slightly "curved / juggled" on the distal side.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an eluvia self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Photos of the device were received from the customer.The photos were reviewed, and they appear to match the same condition as when the device was analyzed.Visual examination revealed that the handle was open.There are pry marks on the bottom of the handle.Microscopic examination revealed scratch marks on the tip.There is damage to the 5th and 6th teeth from the distal end of the pull rack.The middle sheath was separated from the retainer.There was a twist to the outer sheath 8mm from the nosecone.There is buckling to the outer sheath at 54.2cm and 78.5cm from the nosecone.The section of the stent that returned was approximately 10.3cm long.The stent was stretched and separated.The other end of the separation did not return for analysis.Inspection of the remainder of the device, revealed no other damage or irregularities.

Event Description

It was reported that the stent partially deployed, elongated and separated.A piece of the stent remained in the patient and another stent was placed over the fractured stent.The 100% stenosed target lesion was located in the severely calcified and severely tortuous superficial femoral artery (sfa).Contralateral approach was performed and even with the tortuous bifurication, the non-bsc introducer sheath was able to pass without issue.A.035 non-bsc guidewire was used.The first eluvia device was placed at the distal sfa and the during deployment, the thumbwheel went in circles.The stent was successfully deployed using the pull grip.The second device, a 7x120x130 eluvia self expanding stent was then attempted to place with overlap.The thumbwheel was hard to turn and would not deploy the stent.The pull grip did not deloy the stent either.The physician attempted to pull out the stent and sheath together, but part of the stent was attached to the vessel wall.The stent stretched and was brought to the area around the iliac and separated about 3cm at the tip of the bifurication area.The physician attempted to recover it with a radial jaw, but that failed.The physician placed another stent where the fractured stent remained to prevent movement.There were no patient complications.Upon removal, the device looked slightly "curved/juggled" on the distal side.

• 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: 8981634
• MDR Text Key: 157113527
• Report Number: 2134265-2019-10880
• 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

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023622269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Date Manufacturer Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORSAIR PV PROMINENT MICRO CATHETER; CORSAIR PV PROMINENT MICRO CATHETER; COYOTE MASTULY BALLOON CATHETER; COYOTE MASTULY BALLOON CATHETER; DESTINATION INTRODUCER SHEATH; DESTINATION INTRODUCER SHEATH; MACH 1 GUIDE CATHETER; MACH 1 GUIDE CATHETER; RADIOFOCUS .035 ANGURU; RADIOFOCUS .035 ANGURU; CORSAIR PV PROMINENT MICRO CATHETER; COYOTE MASTULY BALLOON CATHETER; DESTINATION INTRODUCER SHEATH; MACH 1 GUIDE CATHETER; RADIOFOCUS .035 ANGURU
• Patient Outcome(s): Required Intervention