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); Vascular Dissection (3160)

Event Date 09/06/2017

Event Type  Injury  

Manufacturer Narrative

Age at time of event: (b)(6) years old at the time of enrollment device is a combination product.(b)(6).

Event Description

It was reported that the patient had an in-stent restenosis of the left superficial femoral artery (sfa).The patient was enrolled in the imperial study on (b)(6) 2016 and the index procedure as performed on the same day.The target lesion was located in the left distal sfa, extending to the proximal popliteal artery with 100% stenosis and was 90 mm long with a proximal reference diameter of 4.3 mm and a distal reference diameter of 5.2 mm and was classified as tasc ii b lesion.The lesion was treated with pre-dilatation and placement of a 6.00 mm x120 mm study stent.Following post-dilatation, the residual stenosis was 0%.On (b)(6) the patient was discharged with dapt.On (b)(6) 2017, the patient visited the hospital for the study specific 12 month follow up.Dus was performed and revealed in-stent stenosis estimated between 50-70% in the left sfa.On (b)(6) 2018, 90% of the in-stent stenosis was treated with balloon angioplasty with 10% residual stenosis.The event was considered resolved the same day.

Manufacturer Narrative

Age at time of event: 53 years old at the time of enrollment device is a combination product.(b)(6).

Event Description

It was reported that the patient had an in-stent restenosis of the left superficial femoral artery (sfa).The patient was enrolled in the imperial study on (b)(6) 2016 and the index procedure as performed on the same day.The target lesion was located in the left distal sfa, extending to the proximal popliteal artery with 100% stenosis and was 90 mm long with a proximal reference diameter of 4.3 mm and a distal reference diameter of 5.2 mm and was classified as tasc ii b lesion.The lesion was treated with pre-dilatation and placement of a 6.00 mm x120 mm study stent.Following post-dilatation, the residual stenosis was 0%.On (b)(6), the patient was discharged with dapt.On (b)(6) 2017, the patient visited the hospital for the study specific 12 month follow up.Dus was performed and revealed in-stent stenosis estimated between 50-70% in the left sfa.On (b)(6) 2018, 90% of the in-stent stenosis was treated with balloon angioplasty with 10% residual stenosis.The event was considered resolved the same day.Additional information reported: on (b)(6) 2018, angiography revealed patent left popliteal stent, severe stenosis in stent further away with velocity of 382 cm/sec and ratio of 10.The left ankle index measure 0.69 in posterior tibial pulses and 0.64 in pedal pulses; which was significantly reduced as compared to doppler in september 2017.The patient was also noted with increased velocity to 205 cm/sec in upper extremity drug-eluting stent, compared to 71 before and to 50 cm/sec slightly further from stent.On (b)(6) 2018, the patient was hospitalized to vascular surgery department with left right claudication.Physicial examination on the same day revealed palpable pedal pulses and posterior tibial pulses.On (b)(6) 2018, arteriography revealed good patency in the left sfa without significant stenosis i its native portion, stent located in adductor canal and extends towards proximal left popliteal artery, severe stenosis in extremity closest to the stent and severe stenosis in extremity furthest from the stent; both estimated around 90%.The isr was treated with 4mm balloon followed by 5x150mm impact drug-eluting balloon angioplasty.Then a 6mmx20mm balloon was inflated inside the portion closest to the stent in adductor canal.Then a 4mm balloon was inflated 3 cm above the stent where the initial drug-eluting stent was inflated.The final angiographic result was good with 10% residual stenosis in extremity closest to the stent and no significant residual stenosis in the rest of the stent or in distal extremity.The patient was noted with small dissection of the native artery above the stent, but no significant stenosis was noted.The flow was rapid and no stent was inserted.On (b)(6) 2018, the event was considered resolved.

• 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: 8129415
• MDR Text Key: 129204703
• Report Number: 2134265-2018-63469
• 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: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 18765492
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: 12/21/2018
• Supplement Dates FDA Received: 01/15/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention