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

Model Number 24653

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2019

Event Type  Injury  

Event Description

It was reported that the stent is not fully apposed to the vessel wall.The chronic total occluded (cto) target lesion was located in the moderately tortuous and severely calcified right superficial femoral artery (sfa).A 7x120x130cm eluvia drug-eluting vascular stent system was placed on (b)(6) 2019.Follow-up of the lesion was performed on (b)(6) 2019 using echo and angiography.It was reported that "there might be gap between the outside of the stent and the vessel wall".However, it was judged that a definitive diagnosis would not be possible without an examination using an angioscope or intravascular ultrasound.It was decided to perform an examination again.On the day of the re-examination, the findings of the optical frequency domain imaging (ofdi) and angioscopy, morphologically, displayed no aneurysm.On (b)(6) 2019, the patient returned and was hospitalized for examination.On (b)(6) 2019, the patient was planned to have left sfa treatment and right sfa vascular endoscope, ofdi inspection and checked by ivus.A stent graft insertion has been 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
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10221019
• MDR Text Key: 197215775
• Report Number: 2134265-2020-08720
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SIMILAR
• 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: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 89 YR