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 Problem Reocclusion (1985)

Event Date 03/25/2019

Event Type  Injury  

Event Description

It was reported that in-stent restenosis occurred.The patient was enrolled in the eminent clinical study.On (b)(6) 2018 the index procedure was performed.The target lesion was located in the right distal superficial femoral artery (sfa).It had a 5.5mm reference vessel diameter proximally and distally.The total length was 60mm visually estimated.The target lesion was 100% occluded and crossed through the true lumen.Two balloons were used for pre-dilation, and afterwards a 6mm x 80 mm eluvia study stent was implanted.Post-dilation was performed using two balloons and the residual stenosis was 5%.On (b)(6) 2019 in-stent restenosis of the target lesion was observed.On (b)(6) 2019 the patient was hospitalized and an interventional procedure of the target lesion was performed.Revascularization of the target lesion was achieved through rotarex, atherectomy and drug-coated balloon treatment.The patient was discharged on (b)(6) 2019.The investigator assessed this event as serious, not related to the index procedure, possibly related to the device and as anticipated.It was assessed as resolved on (b)(6) 2019.

• 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: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8535955
• MDR Text Key: 142632626
• Report Number: 2134265-2019-03484
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0021753956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 60 YR