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

Model Number 24657

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/24/2023

Event Type  Injury  

Manufacturer Narrative

Device analysis: returned product consisted of an eluvia self-expanding stent system.The outer sheath, tip, inner shafts, and the remainder of the device were checked for damage.Visual examination revealed that the handle was open.The pull rack was separate 24.2 cm from the knob.The proximal inner was buckled at the clip.The middle sheath was kinked 2.8 cm and 7.5 cm from the retainer.The outer sheath was buckled 68.8 cm from the nosecone.There were multiple kinks to the inner liner near the tip.Microscopic examination revealed no additional damages.The stent appeared to have been deployed and did not return for analysis.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found damage that would have contributed to deployment issues.

Event Description

It was reported that the stent partially deployed and became stretched as a result.Additional devices were required to adequately treat the target lesion.An eluvia drug-eluting vascular stent system 6x150, 130 cm was selected for use in the arteriogram with atherectomy angioplasty.The target lesion was reported to be 100% stenosed.Prior to stent placement, atherectomy and angioplasty were performed on the target lesion.The eluvia was advanced to the target lesion and the physician began to deploy the stent.After deploying approximately 120 cm, the stent would not release further and began to stretch.The eluvia handle was dismantled to manually deploy the stent.Due to the stent elongating by approximately 80 mm, two additional non-boston scientific stents were placed within the deployed eluvia stent to adequately treat the target lesion.The procedure was successfully completed, and there were no reported complications to the patient.Following removal of the eluvia deployment system, it was noted that there were multiple kinks to the catheter shaft as well as the portion of the catheter within the deployment handle.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18149928
• MDR Text Key: 328297330
• Report Number: 2124215-2023-64494
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876625
• UDI-Public: 08714729876625
• 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
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0030879248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Race: White