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

Model Number 24620

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

Patient Problems Reocclusion (1985); No Consequences Or Impact To Patient (2199)

Event Date 03/07/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that in-stent restenosis occurred.The patient was enrolled in the imperial clinical study on (b)(6) 2016 and the index procedure was performed the same day.The target lesion was located in the left proximal superficial femoral artery (sfa) extending into the left mid sfa with 90% stenosis.The lesion was 145mm long with a proximal target reference vessel diameter of 6mm and distal target reference vessel diameter of 6 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilation and the placement of a 6mm x 150mm eluvia study stent.Following post-dilation, residual stenosis was 0%.On (b)(6) 2019, the patient presented to the hospital with claudication and was diagnosed with peripheral artery disease.There was 90% in-stent restenosis noted in the right sfa.The restenosis was treated with atherectomy and drug coated balloon angioplasty.Final result was 0% restenosis.There were no patient complications reported.

Manufacturer Narrative

Device is a combination product.Describe event or problem was corrected to include that the adverse event was not related to the eluvia stent.Outcomes attrib to adv event was corrected from required intervention to prevent permanent impairment/damage to none.Patient codes were corrected from reocclusion to no consequence or impact to patient.

Event Description

It was reported that in-stent restenosis occurred.The patient was enrolled in the imperial clinical study on november 10, 2016 and the index procedure was performed the same day.The target lesion was located in the left proximal superficial femoral artery (sfa) extending into the left mid sfa with 90% stenosis.The lesion was 145mm long with a proximal target reference vessel diameter of 6mm and distal target reference vessel diameter of 6 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilation and the placement of a 6mm x 150mm eluvia study stent.Following post-dilation, residual stenosis was 0%.On (b)(6) 2019, the patient presented to the hospital with claudication and was diagnosed with peripheral artery disease.There was 90% in-stent restenosis noted in the right sfa.The restenosis was treated with atherectomy and drug coated balloon angioplasty.Final result was 0% restenosis.There were no patient complications reported.It was further reported and corrected that the claudication occurred in the right lower extremity and 90% in-stent restenosis noted in the right sfa.As the complaint stent was implanted in the left sfa, this event was considered not related to the device.

• Brand Name: ELUVIATM 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
• MDR Report Key: 8483578
• MDR Text Key: 140929889
• Report Number: 2134265-2019-03393
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 0018822232
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR