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 Problem Reocclusion (1985)

Event Date 09/11/2019

Event Type  Injury  

Event Description

It was reported that in-stent restenosis occurred.The subject was enrolled in the (b)(6) clinical study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was located in the right mid superficial femoral artery (sfa) with 100% stenosis.The target lesion was 190 mm long with a proximal reference vessel diameter of 5.0 mm and distal vessel diameter of 4.5 mm and was classified as tasc ii c lesion.The target lesion was treated with pre-dilatation and placement of two 6.0 x 150 mm eluvia study stents.Following post-dilatation, residual stenosis was 10%.On (b)(6) 2019, the subject was noted to have in-stent restenosis in the right sfa.On (b)(6) 2019, 1093 days post-index procedure, the subject was hospitalized for further evaluation and treatment.90% in-stent restenosis was noted in the right sfa.It was treated with a drug-coated balloon with final residual stenosis of 20%.No thrombus was seen.On (b)(6) 2019 the event was considered resolved and the subject was discharged on the same day.

Event Description

It was reported that in-stent restenosis occurred.The subject was enrolled in the imperial clinical study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was located in the right mid superficial femoral artery (sfa) with 100% stenosis.The target lesion was 190 mm long with a proximal reference vessel diameter of 5.0 mm and distal vessel diameter of 4.5 mm and was classified as tasc ii c lesion.The target lesion was treated with pre-dilatation and placement of two 6.0 x 150 mm eluvia study stents.Following post-dilatation, residual stenosis was 10%.On (b)(6) 2019, the subject was noted to have in-stent restenosis in the right sfa.On (b)(6) 2019, 1093 days post-index procedure, the subject was hospitalized for further evaluation and treatment.90% in-stent restenosis was noted in the right sfa.It was treated with a drug-coated balloon with final residual stenosis of 20%.No thrombus was seen.On (b)(6) 2019 the event was considered resolved and the subject was discharged on the same day.It was further reported that during the index procedure on (b)(6) 2016 pre- index procedure angiography revealed stenosis in the proximal sfa and chronic total occlusion across the sfa.The subject was recommended for deployment of study stents in the target lesion.During the procedure a jupiter tapered 45 guide wire was attempted to approach proximal sfa however it could not pass through the lesion.Hence right distal sfa punctured directly and jupiter fc guide wire was attempted to progress upward towards proximal sfa, however this was unsuccessful.On (b)(6) 2016 the subject was discharged on dual antiplatelet medications.On (b)(6) 2019, the subject was presented to the hospital for a 36 month follow up, during which he was diagnosed to have obstructive arteriosclerosis of lower extremity.Subsequently, duplex ultrasound was performed which revealed in the right limb the presence of stent in the proximal right mid sfa which seemed to be interrupted and stretched; suspected to be irregular and ruptured section at 5cm inside the stent, severe stenosis and accelerated blood flow was observed in this area.Mild to moderate stenosis was observed in the second stent with no accelerated blood flow.Peak systolic velocity was 296cm/s and peak systemic velocity ratio was 4.9.Based on the above findings, no action was taken at that point of time.On (b)(6) 2019 the subject again presented to the hospital with the complaint of pain in his right lower extremity dorsum.Subsequently angiography was performed which revealed arteriosclerosis progression inside of study stent and ruptured site.On the same day, 1155 days post-index procedure, 90% stenosis noted in the right sfa including the stented region and ruptured site (stent fractures noted during index procedure) was treated by performing drug coated ballooning using a non-bsc balloon at distal sfa and a non-bsc balloon to the proximal sfa with 0% residual stenosis.Per edc and source no thrombus was seen.Per core lab finding dated september 13, 2016, axial stent deformation was noted.Per x-ray core lab, dated (b)(6) 2017, a grade v stent fracture(s) was noted in the study stent.

Manufacturer Narrative

Device is a combination product.

• 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: 9353742
• MDR Text Key: 167347367
• Report Number: 2134265-2019-14169
• 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: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• 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: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR