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 Problems Thrombosis (2100); No Code Available (3191)

Event Date 05/04/2020

Event Type  Injury  

Event Description

It was reported that rethrombosis occurred.On (b)(6) 2018, the subject was implanted with an eluvia device in the proximal superficial femoral artery (sfa).On (b)(6) 2020, the subject was enrolled into (b)(6) and a 3.5mm x 80mm study stent was placed.On (b)(6) 2020, subject presented to emergency department with one-week history of right lower leg calf pain.On the same day, the subject was hospitalized for further evaluation and treatment.On physical examination, right lower leg was found to be cooler than left lower leg with diminished pulses.Subject also had moderate tenderness in the right hip.Subject had mild dementia and does not recall any injury or trauma or unusual activity that may have caused the pain.At present, the pain experienced was moderate.Arteria duplex exam revealed obstruction of flow possibly from a thrombus in the stent.On (b)(6) 2020, the subject underwent abdominal aortogram and right lower extremity angiography which revealed interval re-thrombosis of previously implanted study stent within the right anterior tibial artery and rethrombosis of eluvia stent in the proximal sfa.As a treatment for the occlusion, mechanical thrombectomy was performed using a non-bsc catheter on the entire sfa through the stented segment until the distal sfa with multiple passes was made.The anterior tibial artery appeared to be occluded again at the level of the previously placed stent.Tissue plasminogen activator (tpa) was infused at 1mg/h for 24 hrs.On (b)(6) 2020, the subject underwent right lower extremity angiography which revealed anterior tibial artery being thrombosed proximally and the stent was patent and there was a mild dissection seen below the stent.A non-bsc guidewire was crossed down through the dorsalis pedis artery.Additionally, thrombectomy was performed with multiple passes using a non-bsc aspiration catheter which removed extensive thrombus within the target lesion.Further percutaneous transluminal angioplasty (pta) was performed using a 2.5 x 220 mm and a 3.0 x 220 mm coyote balloon.Due to residual thrombus it was decided for thrombolysis procedure with a non-bsc infusion catheter and infused tpa at 1/2 mg/h for 24 hours.Revision angiography was planned on (b)(6) 2020.On (b)(6) 2020, the subject again underwent right lower extremity angiography, revealed flow through the anterior tibial but there was still evidence of thrombus within the proximal section of the study stent.Further treatment was continued with crossing with a non-bsc guidewire down through the dorsalis pedis artery.A non-bsc distal access catheter was used to carefully cross through the tack stent that was above the study stent and performed mechanical thrombectomy removing large plugs of clot.Further pta was done with 3.0 x 100 mm coyote balloon and inflated this to 12 atm for 3 minutes.Residual thrombus was again treated with a non-bsc distal access catheter but disruption occurred to the tack stent which then migrated to the proximal study stent.Pta was again performed using coyote balloon.Intravascular ultrasound was performed with a non-bsc ivus catheter and this revealed extensive dissection below the patent eluvia stent within the proximal sfa.The target lesion appeared to be patent proximally but there was still residual thrombus noted along with the mangled tack in the (b)(6) stent which was treated with 3.0 x 23 mm non-bsc drug-eluting stent.Again, pta was performed for study stent using 3.0 x 100 mm coyote balloon which showed markedly improved flow.Areas of dissection were marked using ivus, then pta was performed using a 6 x 120 mm non-bsc drug coated balloon (dcb).After this, 5 tack stents were placed within the mid sfa and then one tack stent just below the eluvia stent in the proximal sfa.Post-dilatation was performed using a 6 x 60 mm sterling balloon at 14 atm.Final angiography revealed brisk flow with no significant residual dissection.There was intact single-vessel runoff to the foot.Subject was recommended to continue on medications of plavix.At the time of reporting, the event was considered to be not recovered/not resolved.

Event Description

It was reported that rethrombosis occurred.On (b)(6) 2018, the subject was implanted with an eluvia device in the proximal superficial femoral artery (sfa).On (b)(6) 2020, the subject was enrolled into the saval pivotal study and a 3.5mm x 80mm study stent was placed.On (b)(6) 2020, subject presented to emergency department with one-week history of right lower leg calf pain.On the same day, the subject was hospitalized for further evaluation and treatment.On physical examination, right lower leg was found to be cooler than left lower leg with diminished pulses.Subject also had moderate tenderness in the right hip.Subject had mild dementia and does not recall any injury or trauma or unusual activity that may have caused the pain.At present, the pain experienced was moderate.Arteria duplex exam revealed obstruction of flow possibly from a thrombus in the stent.On (b)(6) 2020, the subject underwent abdominal aortogram and right lower extremity angiography which revealed interval re-thrombosis of previously implanted study stent within the right anterior tibial artery and rethrombosis of eluvia stent in the proximal sfa.As a treatment for the occlusion, mechanical thrombectomy was performed using a non-bsc catheter on the entire sfa through the stented segment until the distal sfa with multiple passes was made.The anterior tibial artery appeared to be occluded again at the level of the previously placed stent.Tissue plasminogen activator (tpa) was infused at 1mg/h for 24 hrs.On (b)(6) 2020, the subject underwent right lower extremity angiography which revealed anterior tibial artery being thrombosed proximally and the stent was patent and there was a mild dissection seen below the stent.A non-bsc guidewire was crossed down through the dorsalis pedis artery.Additionally, thrombectomy was performed with multiple passes using a non-bsc aspiration catheter which removed extensive thrombus within the target lesion.Further percutaneous transluminal angioplasty (pta) was performed using a 2.5 x 220 mm and a 3.0 x 220 mm coyote balloon.Due to residual thrombus it was decided for thrombolysis procedure with a non-bsc infusion catheter and infused tpa at 1/2 mg/h for 24 hours.Revision angiography was planned on (b)(6) 2020.On (b)(6) 2020, the subject again underwent right lower extremity angiography, revealed flow through the anterior tibial but there was still evidence of thrombus within the proximal section of the study stent.Further treatment was continued with crossing with a non-bsc guidewire down through the dorsalis pedis artery.A non-bsc distal access catheter was used to carefully cross through the tack stent that was above the study stent and performed mechanical thrombectomy removing large plugs of clot.Further pta was done with 3.0 x 100 mm coyote balloon and inflated this to 12 atm for 3 minutes.Residual thrombus was again treated with a non-bsc distal access catheter but disruption occurred to the tack stent which then migrated to the proximal study stent.Pta was again performed using coyote balloon.Intravascular ultrasound was performed with a non-bsc ivus catheter and this revealed extensive dissection below the patent eluvia stent within the proximal sfa.The target lesion appeared to be patent proximally but there was still residual thrombus noted along with the mangled tack in the proximal study stent which was treated with 3.0 x 23 mm non-bsc drug-eluting stent.Again, pta was performed for study stent using 3.0 x 100 mm coyote balloon which showed markedly improved flow.Areas of dissection were marked using ivus, then pta was performed using a 6 x 120 mm non-bsc drug coated balloon (dcb).After this, 5 tack stents were placed within the mid sfa and then one tack stent just below the eluvia stent in the proximal sfa.Post-dilatation was performed using a 6 x 60 mm sterling balloon at 14 atm.Final angiography revealed brisk flow with no significant residual dissection.There was intact single-vessel runoff to the foot.Subject was recommended to continue on medications of plavix.At the time of reporting, the event was considered to be not recovered/not resolved.It was further reported that on (b)(6) 2020, baseline angio core lab analysis at right anterior tibial artery revealed thrombus at grade 0, mild calcification and absence of ulceration and aneurysm.On (b)(6) 2020, angiography core lab analysis at right anterior tibial revealed thrombus at grade 0, absence of aneurysm, timi flow at 0 and restenosis pattern as 4.On (b)(6) 2020, the event was consider resolved.On (b)(6) 2020, the event was considered as recovered and on same day the subject was discharged to home.On j(b)(6) 2020, angiography core lab analysis at right anterior tibial revealed thrombus at grade 4, absence of aneurysm, timi flow at 3 and restenosis pattern as 1c with a length of 9.50 mm.

• 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: 10119325
• MDR Text Key: 194122220
• Report Number: 2134265-2020-07473
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR