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 Consequences Or Impact To Patient (2199)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(6).

Event Description

It was reported that the stent partially deployed.The 95% stenosed target lesion was located in the moderately calcified and moderately tortuous left superficial femoral artery (sfa).The lesion was accessed from the left elbow artery over a 0.014" guidewire.Pre-dilation was performed.A 7mmx120mm, 130 cm eluvia drug-eluting vascular stent system was selected for use.The stent partially deployed during use and became stretched approximately 3cm.The stenting procedure was completed with this device.Post dilation with a balloon was performed.There were no patient complications reported.

Manufacturer Narrative

A2: age at time of event - 18 years or older.E1: initial reporter address 1 - (b)(6).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 a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The stent was deployed and did not return for analysis.The handle was disassembled, and the proximal inner was prolapsed.Inspection of the remainder of the device revealed no other damage or irregularities.

Event Description

It was reported that the stent partially deployed.The 95% stenosed target lesion was located in the moderately calcified and moderately tortuous left superficial femoral artery (sfa).The lesion was accessed from the left elbow artery over a 0.014" guidewire.Pre-dilation was performed.A 7mmx120mm, 130 cm eluvia drug-eluting vascular stent system was selected for use.The stent partially deployed during use and became stretched approximately 3cm.The stenting procedure was completed with this device.Post dilation with a balloon was performed.There were no patient complications reported.

• 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: 11003628
• MDR Text Key: 221298644
• Report Number: 2134265-2020-17638
• 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: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0024595459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 014INCH JUPITER FC3 GUIDEWIRE; 014INCH JUPITER FC3 GUIDEWIRE; 014INCH JUPITER FC3 GUIDEWIRE