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

Model Number 24653

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Swelling (2091)

Event Date 06/07/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter city: (b)(6).

Event Description

It was reported that the patient experienced fever and swelling of the legs.A 6x80, 130 cm eluvia drug-eluting vascular stent system was selected for a patient procedure.The stent was implanted in the mid left superficial femoral artery (sfa) on (b)(6) 2019.The patient then complained of fever and swelling of the legs four days later.The procedure was performed from the right common femoral artery by contralateral approach.A non-bsc sheath was advanced to the origin part of the left sfa, and a jupiterfc3 guidewire crossed the lesion.After that, a measurement was performed in the blood vessel with ivus and size selection of a pre-balloon and eluvia was performed.The blood vessel diameter was about 5.8 mm.The pre-balloon used was an unspecified 5mm.After pre-ballooning the lesion, the guidewire was replaced with non-bsc guidewire, and eluvia was placed.There was nothing unusual about the placement.The guidewire was replaced with jupiterfc3, and post-balloon was performed by an unspecified 5mm balloon.The status of the stent was checked by ivus, and the procedure was completed.The physician does not think eluvia is the cause of the fever and swelling of the legs.No further complications were 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8744427
• MDR Text Key: 149511066
• Report Number: 2134265-2019-07554
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2020
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023104787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2018
• 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
• Treatment: DESTINATION SHEATH; RADIFOCUS GUIDEWIRE
• Patient Outcome(s): Other