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

Model Number 24653

Device Problem Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2020

Event Type  Injury  

Manufacturer Narrative

Age at time of event: patient was over 18 years old.

Event Description

It was reported that stent migration occurred.A 7x60x130 eluvia self expanding drug eluting stent was implanted in patient's common femoral artery on (b)(6) 2020.An abdominal aortic aneurysm (aaa) stent grafting procedure was performed on (b)(6) 2020.When the pigtail catheter used to image the placement of the aaa stent graft was inserted, the eluvia stent moved into the aorta.The physician used an 8mm balloon in the eluvia stent and pulled it back into the common femoral artery.There were no patient complications and the physician was happy with the final placement of the eluvia stent.

• 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: 10080483
• MDR Text Key: 191803146
• Report Number: 2134265-2020-06847
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P180011
• 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: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023276240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention