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

Model Number 24653

Device Problem Fracture (1260)

Patient Problems Pain (1994); Obstruction/Occlusion (2422)

Event Date 05/31/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter city: (b)(6).

Event Description

It was reported that the stent fractured and occluded.The patient experienced pain due to this.A 6x120 cm eluvia drug-eluting vascular stent system was selected for the patient procedure on (b)(6) 2020.The patient had peripheral artery disease.The lesion was moderately tortuous, 100% stenosed, and severely calcified.The treatment site was a chronic total occlusion at the left superficial femoral artery and popliteal artery.The stent was placed from "p1 to p2." on (b)(6) 2021, the patient presented to the physician due to pain in the lower limb.When examined, the distal side (p2 part) of the eluvia was separated.Follow-up contrast was performed and found an occlusion within the eluvia.Collateral circulation was noted, so below the knee circulation has persisted due to the blood flow from the collateral circulation.A high fracture tolerance of the eluvia stent was found, and it was stated that the location where the device was placed (p2) was not good.No additional interventions or adverse effects were reported.A bypass surgery will be scheduled sometime in the future; it has not yet been scheduled.

• 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12046012
• MDR Text Key: 257719185
• Report Number: 2134265-2021-07883
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2021

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: 11/14/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0024941648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2021
• Initial Date FDA Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR