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

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

Patient Problem Reocclusion (1985)

Event Date 10/22/2018

Event Type  Injury  

Manufacturer Narrative

Initial reporter title: author.Device is a combination product.

Event Description

Reported via journal article that the patient experienced in-stent restenosis.The case was regarding a patient with left leg peripheral artery occlusive disease with severe calcification & chronic total occlusion over the superficial femoral artery (sfa).The patient presented with a poorly healing left foot wound that had been present for 6 months, and intermittent claudication for several months.Physical examination revealed her left foot big toe and 3rd toe had poor healing wounds and both feet were mildly cold.On (b)(6) 2018, the patient underwent a procedure.The lesion was approached via the right femoral artery.Percutaneous transluminal angioplasty (pta) for the left iliac artery was done with an antegrade approach.However, they could not get into the distal true lumen, so they shifted to the retrograde approach; the retrograde wire entered into the proximal cfa.Then angioplasty from an antegrade approach was completed.Several unspecified balloons were used for severe calcification of the cfa & sfa.After angioplasty, stenting was done with an eluvia stent from proximal to middle sfa, and one unspecified bms for distal sfa.However, immediately vessel recoil was noted due to severe calcification, so they performed post-dilatation.The lesions still recoiled after post-dilatation.To avoid further vessel recoil and reocclusion, a non-bsc catheter was inserted into the popliteal artery.The physician then performed catheter directed thrombolysis (cdt) treatment for below the knee lesions first, and evaluated the lesions later.On (b)(6) 2018, a left leg angiography showed 70% stenosis and in-stent restenosis (isr) due to recoil and calcification in the sfa.Angioplasty for ata, pta & dorsal-plantal loop was done.Angioplasty for sfa was done with a non-bsc balloon (6 x40 mm).The physician inserted a heparin-coated non-bsc stent for isr for support and post-dilatation.Ata blood flow was still slow, so they inserted a non-bsc catheter for cdt treatment.On (b)(6) 2018, left leg angiography showed that the sfa distal stent edge with thrombus lesion with 50-70% stenosis and dorsal pedis with some thrombus.Angioplasty for sfa, popliteal an ata, pta, the plantar loop was done.Relatively good blood flow regained.Even after recanalization of left sfa total occlusion by angioplasty & stenting, sfa still soon recoiled after stenting.Debulking for calcified chronic total occlusion was not performed in this case due to an economic issue.Therefore, double layer stents technique was used to conquer the severe recoil phenomenon after recanalization of severe calcified chronic total occlusion of left sfa.The result seemed good after intensive post-dilatation after double layer stents inserted.Reference: chang c, et al.(2019).Tctap c-188 double layer stents technique to conquer the severe recoil phenomenon after recanalization of severe calcified chronic total occlusion of left superficial femoral artery.Journal of the american college of cardiology 2019, s249-s251.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8612735
• MDR Text Key: 145139766
• Report Number: 2134265-2019-04638
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR