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

Model Number 24657

Device Problems Break (1069); Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/20/2023

Event Type  Injury  

Event Description

It was reported that the catheter of the delivery system became stuck on the stent, and both the stent and catheter tip broke off within the patient.An endarterectomy was performed to remove the stent and catheter fragments.A 6x80, 130 cm eluvia drug-eluting vascular stent system was selected for use in the procedure.The target lesion was located in the superficial femoral artery (sfa) and was reported to have both moderate tortuosity and calcification.When advancing the delivery system to the target lesion, there was resistance noted.When the stent was fully deployed, it would not release from the catheter.The catheter of the delivery system became stuck on the stent, and both the stent and catheter tip broke off within the patient.An endarterectomy was performed to remove the stent and fragment of the catheter.The stent was fully intact until it was retrieved.It was unknown whether any device fragments remained within the patient.There were no further adverse consequences reported for the patient post procedure.The patient's status was ok.

Manufacturer Narrative

Device analysis: returned product consisted of an eluvia self-expanding stent system with an unknown 0.035in hydrophilic guidewire stuck inside 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 partially open.The pull rack was separated at the handle.The proximal section of the pull rack was missing.The inner liner was kinked at the distal end of the proximal inner and 1cm from the distal end of the proximal inner.The inner liner was separated 22mm from the tip.The stent returned damaged and in four pieces.With the pieces lined up, it measured less than 70mm.Both ends of the radiopaque markers were present.Microscopic examination revealed no additional damages.The handle was x-rayed, and no additional damages were found.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found damage that would have contributed to the reported event.

Event Description

It was reported that the catheter of the delivery system became stuck on the stent, and both the stent and catheter tip broke off within the patient.An endarterectomy was performed to remove the stent and catheter fragments.A 6x80, 130 cm eluvia drug-eluting vascular stent system was selected for use in the procedure.The target lesion was located in the superficial femoral artery (sfa) and was reported to have both moderate tortuosity and calcification.When advancing the delivery system to the target lesion, there was resistance noted.When the stent was fully deployed, it would not release from the catheter.The catheter of the delivery system became stuck on the stent, and both the stent and catheter tip broke off within the patient.An endarterectomy was performed to remove the stent and fragment of the catheter.The stent was fully intact until it was retrieved.It was unknown whether any device fragments remained within the patient.There were no further adverse consequences reported for the patient post procedure.The patient's status was ok.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• 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: 16953630
• MDR Text Key: 315473455
• Report Number: 2124215-2023-24316
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876595
• UDI-Public: 08714729876595
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0028307257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention