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 Occlusion (1984); No Code Available (3191)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).

Event Description

It was reported that in-stent occlusion occurred.The patient underwent treatment with the eluvia device on (b)(6) 2020 as part of the regal clinical trial.The target lesion was located in ostial, proximal, mid, and distal left superficial femoral artery (sfa), involving proximal popliteal artery (ppa) with 100% stenosis.The target lesion was 300mm long, with a proximal and a distal vessel diameter of 5mm.The lesion was treated with pre-dilatation and the lesion was crossed subintimal.Three 6x100mm eluvia stent, one 6x80mm eluvia stent, and one 6x60mm eluvia stent were placed.Following post dilatation, residual stenosis was 0%.No thrombus was seen in the treated vessel at the end of the procedure.On (b)(6) 2020, a stent occlusion of left sfa was observed.The patient was hospitalized and femopop 3 (fp3) bypass of the left sfa will be performed on (b)(6) 2020.At the time of reporting, the event was ongoing.

Manufacturer Narrative

A1: patient identifier: (b)(6).

Event Description

It was reported that in-stent occlusion occurred.The patient underwent treatment with the eluvia device on (b)(6) 2020 as part of the regal clinical trial.The target lesion was located in ostial, proximal, mid, and distal left superficial femoral artery (sfa), involving proximal popliteal artery (ppa) with 100% stenosis.The target lesion was 300mm long, with a proximal and a distal vessel diameter of 5mm.The lesion was treated with pre-dilatation and the lesion was crossed subintimal.Three 6x100mm eluvia stent, one 6x80mm eluvia stent, and one 6x60mm eluvia stent were placed.Following post dilatation, residual stenosis was 0%.No thrombus was seen in the treated vessel at the end of the procedure.On (b)(6) 2020, a stent occlusion of left sfa was observed.The patient was hospitalized and femopop 3 (fp3) bypass of the left sfa will be performed on (b)(6) 2020.At the time of reporting, the event was ongoing.It was further reported that the event was considered to be resolved on (b)(6) 2020.

• 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
• MDR Report Key: 10540345
• MDR Text Key: 207130423
• Report Number: 2134265-2020-12730
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2020
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023179735
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR