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

Model Number 24653

Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2020

Event Type  Injury  

Event Description

It was reported that the stent partially deployed.The 100% stenosed target lesion was located in the severely tortuous and severely calcified right superficial femoral artery (sfa).The lesion was crossed with a 0.035 guidewire and ballooning was performed.A 7mm x 120mm, 130 cm eluvia drug-eluting vascular stent system was advanced for implantation in the proximal sfa.Hot water flush was used.When the stent was attempted to be deployed, the stent was unable to be deployed after 2/3.Biopsy forceps were used to dissect the stent and remove the system.The stent was fractured and a portion remained inside the patient.A different stent was placed to overlap the fractured segment.Post dilation was performed and the procedure was completed successfully.There were no patient complications reported.

Event Description

It was reported that the stent partially deployed.The 100% stenosed target lesion was located in the severely tortuous and severely calcified right superficial femoral artery (sfa).The lesion was crossed with a 0.035 guidewire and ballooning was performed.A 7mmx120mm, 130 cm eluvia drug-eluting vascular stent system was advanced for implantation in the proximal sfa.Hot water flush was used.When the stent was attempted to be deployed, the stent was unable to be deployed after 2/3.Biopsy forceps were used to dissect the stent and remove the system.The stent was fractured and a portion remained inside the patient.A different stent was placed to overlap the fractured segment.Post dilation was performed and the procedure was completed successfully.There were no patient complications reported.It was further reported that the stent was elongated due to detachment.The sheath was noted to be detached, and kinks were observed.

Event Description

It was reported that the stent partially deployed.The 100% stenosed target lesion was located in the severely tortuous and severely calcified right superficial femoral artery (sfa).The lesion was crossed with a 0.035 guidewire and ballooning was performed.A 7mmx120mm, 130 cm eluvia drug-eluting vascular stent system was advanced for implantation in the proximal sfa.Hot water flush was used.When the stent was attempted to be deployed, the stent was unable to be deployed after 2/3.Biopsy forceps were used to dissect the stent and remove the system.The stent was fractured and a portion remained inside the patient.A different stent was placed to overlap the fractured segment.Post dilation was performed and the procedure was completed successfully.There were no patient complications reported.It was further reported that the stent was elongated due to detachment.The sheath was noted to be detached, and kinks were observed.

Manufacturer Narrative

Device eval by manufacturer: returned product consisted of an eluvia self-expanding stent system with a 0.014 inch guidewire stuck in the device.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual examination revealed that the handle was missing.The sheath was stuck onto the guide catheter.There were multiple bucklings on the sheath.The proximal inner was prolapsed.Microscopic examination revealed no additional damages.The stent was stretched and separated.The proximal section of the stent appeared to be stuck inside the guide catheter while the distal section of the stent was missing.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found damage that would have contributed to deployment issues.

• 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: 11207434
• MDR Text Key: 227951705
• Report Number: 2134265-2021-00499
• 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,Followup
• Report Date: 02/26/2021

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: 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: 01/21/2021
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 01/19/2021; 02/11/2021
• Supplement Dates FDA Received: 01/27/2021; 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR