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

Model Number 24653

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2023

Event Type  malfunction  

Event Description

It was reported that the eluvia drug-eluting vascular stent system partially deployed and the stent was stretched as a result.An eluvia drug-eluting vascular stent system was selected for use to treat the chronic total occlusion of the mid left superficial femoral artery (sfa).The target lesion was reported to be 100% stenosed at the ostium with mild tortuosity.A non-bsc guide sheath was placed and a non-bsc guidewire was advanced from the retrograde.A coyote es was advanced to perform pre-dilation.After successfully inflating twice to 14 atm., the balloon ruptured on the third inflation attempt.The balloon was replaced with a non-bsc balloon in order to complete vessel pre-dilation.An eluvia drug-eluting vascular stent system was advanced distally through an antegrade approach and deployed without issue.A second eluvia drug-eluting vascular stent system was advanced to the target lesion and the thumbwheel was rotated.The second stent was deployed approximately 2-3 cm from the tip of the catheter, at which point deployment ceased.There was no resistance felt in the thumbwheel when rotating.The entire system was pulled, causing the stent to stretch.When deployment was attempted, the common femoral artery was jailed, so the stent was deployed within the external iliac artery.The intended target location was within the sfa ostium, but ideal placement was unable to be performed due to device deficiency.Additional imaging was able to confirm blood flow, although the physician noted the potential for future blood clot formation in the vessel portions where the stent was stretched.The procedure was completed and there were no additionally reported consequences to the patient.

Event Description

It was reported that the eluvia drug-eluting vascular stent system partially deployed and the stent was stretched as a result.An eluvia drug-eluting vascular stent system was selected for use to treat the chronic total occlusion of the mid left superficial femoral artery (sfa).The target lesion was reported to be 100% stenosed at the ostium with mild tortuosity.A non-bsc guide sheath was placed and a non-bsc guidewire was advanced from the retrograde.A coyote es was advanced to perform pre-dilation.After successfully inflating twice to 14 atm., the balloon ruptured on the third inflation attempt.The balloon was replaced with a non-bsc balloon in order to complete vessel pre-dilation.An eluvia drug-eluting vascular stent system was advanced distally through an antegrade approach and deployed without issue.A second eluvia drug-eluting vascular stent system was advanced to the target lesion and the thumb wheel was rotated.The second stent was deployed approximately 2-3 cm from the tip of the catheter, at which point deployment ceased.There was no resistance felt in the thumb wheel when rotating.The entire system was pulled, causing the stent to stretch.When deployment was attempted, the common femoral artery was jailed, so the stent was deployed within the external iliac artery.The intended target location was within the sfa ostium, but ideal placement was unable to be performed due to device deficiency.Additional imaging was able to confirm blood flow, although the physician noted the potential for future blood clot formation in the vessel portions where the stent was stretched.The procedure was completed and there were no additionally reported consequences to the patient.

Manufacturer Narrative

Device media analysis: returned product consisted of an eluvia self-expanding stent system with an unknown 0.014 in.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 outer sheath was kinked at the nosecone.Microscopic examination revealed no additional damages.The stent was deployed and did not return for analysis.The handle was x-rayed, and the proximal inner was prolapsed.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found damage that would have contributed to the deployment issue.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16648693
• MDR Text Key: 312414501
• Report Number: 2124215-2023-14779
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2024
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0029388103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COYOTE ES; COYOTE ES