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); Reocclusion (1985); Claudication (2550)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).Date of birth: (b)(6).

Event Description

It was reported that reocclusion occurred.The patient underwent treatment with the eluvia stent on (b)(6) 2017 as part of the eminent clinical trial.The target lesion, located in the middle superficial femoral artery (sfa) of the left leg, had a 6mm reference vessel diameter proximal and distal and a total length of 40mm visually estimated.The target lesion was 85% occluded and crossed subintimally.No pre-dilatation was performed and an the 7x40mm eluvia stent was implanted.Post-dilatation was performed using one balloon, and 0% residual stenosis remained.On (b)(6) 2019, the patient was hospitalized and an angioplasty of the left sfa took place.The patient was discharged and the event was reported as resolved on (b)(6) 2019.

Manufacturer Narrative

A1: patient identifier: (b)(6).A2: date of birth: 1950.

Event Description

It was reported that reocclusion occurred.The patient underwent treatment with the eluvia stent on (b)(6) 2017 as part of the eminent clinical trial.The target lesion, located in the middle superficial femoral artery (sfa) of the left leg, had a 6mm reference vessel diameter proximal and distal and a total length of 40mm visually estimated.The target lesion was 85% occluded and crossed subintimally.No pre-dilatation was performed and an the 7x40mm eluvia stent was implanted.Post-dilatation was performed using one balloon, and 0% residual stenosis remained.On (b)(6) 2019, the patient was hospitalized and an angioplasty of the left sfa took place.The patient was discharged and the event was reported as resolved on (b)(6) 2019.It was further reported that debilitating claudication of the left leg of the patient occurred 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
• MDR Report Key: 9035829
• MDR Text Key: 160065438
• Report Number: 2134265-2019-11194
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0019450595
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR