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); Pain (1994); Thrombosis (2100)

Event Date 12/17/2018

Event Type  Injury  

Event Description

It was reported that stent occlusion occurred.The patient was enrolled in the (b)(6) clinical study on (b)(6) 2017, and the index procedure was performed the same day.The target lesion was 100% stenosed, located in the left mid superficial femoral artery (sfa), extending in to the left distal sfa.The target lesion was 140mm long, with a proximal and distal reference vessel diameter of 5mm, and was classified as a tasc ii b lesion.The lesion was treated with pre-dilatation.A 6x100mm eluvia stent and a 6x60mm eluvia stent was then placed.Following post dilation, residual stenosis was 0%.On (b)(6) 2018, the left sfa was noted to have restenosis.On (b)(6) 2018, the patient was noted to have cold feet of the left leg.On (b)(6) 2018, the patient was hospitalized and underwent a bilateral lower extremity angiography and duplex ultrasound.Imaging revealed reocclusion of the sfa stents and the left sfa was proximally occluded, and the popliteal artery was occluded completely.The occlusion was treated with thrombectomy, balloon angioplasty, and atherectomy.On (b)(6) the patient complained of left leg pain again.Duplex ultra sound revealed total occlusion in the left sfa and popliteal artery again.The artery was treated with aspiration thrombectomy.On (b)(6) the patient had a hard tender calf with no flow observed in the trifurcation vessels under angiography.The patient underwent catheter aspiration thrombectomy and balloon angioplasty of the anterior tibial and peroneal artery.The vessels were open but poor flow was noted and the patient had pain in both legs.On (b)(6) the patient was noted to have a cold left leg with no motor or sensory function.The patient then underwent an above the knee amputation of the left leg.

Event Description

It was reported that stent occlusion occurred.The patient was enrolled in the imperial clinical study on (b)(6) 2017, and the index procedure was performed the same day.The target lesion was 100% stenosed, located in the left mid superficial femoral artery (sfa), extending in to the left distal sfa.The target lesion was 140mm long, with a proximal and distal reference vessel diameter of 5mm, and was classified as a tasc ii b lesion.The lesion was treated with pre-dilatation.A 6x100mm eluvia stent and a 6x60mm eluvia stent was then placed.Following post dilation, residual stenosis was 0%.On (b)(6) 2018, the left sfa was noted to have restenosis.On (b)(6) 2018, the patient was noted to have cold feet of the left leg.On (b)(6) 2018, the patient was hospitalized and underwent a bilateral lower extremity angiography and duplex ultrasound.Imaging revealed reocclusion of the sfa stents and the left sfa was proximally occluded, and the popliteal artery was occluded completely.The occlusion was treated with thrombectomy, balloon angioplasty, and atherectomy.On (b)(6), the patient complained of left leg pain again.Duplex ultra sound revealed total occlusion in the left sfa and popliteal artery again.The artery was treated with aspiration thrombectomy.On (b)(6) the patient had a hard tender calf with no flow observed in the trifurcation vessels under angiography.The patient underwent catheter aspiration thrombectomy and balloon angioplasty of the anterior tibial and peroneal artery.The vessels were open but poor flow was noted and the patient had pain in both legs.On (b)(6), the patient was noted to have a cold left leg with no motor or sensory function.The patient then underwent an above the knee amputation of the left leg.It was further reported that during the same hospital stay when the leg amputation was performed, the patient was note to have hyponatremia, rhabdomyolysis, acute blood loss anemia, and skin lesions.On (b)(6) 2018, the patient underwent irrigation and debridement of skin, subcutaneous fat, fascia, muscle, and bone, as there was residual avascular necrosis noted post amputation.On the same day, the patient had a negative pressure wound vac with an excellent seal.The patient was recommended for repeat debridement.On (b)(6) 2018, the deep tissues that were found to be necrotic were debrided and the wound was irrigated with 3l of saline.The deep fascia and subcutaneous tissue wee closed.On (b)(6) 2019, the patient was discharged to a rehabilitation center.On (b)(6) 2019, the patient presented to the hospital with complaint of incisional bleeding and knee pain of the left leg stump.The patient was hospitalized the same day.On (b)(6) 2019, the patient was treated by performing excisional debridement of skin, soft tissue, and muscle anteriorly and posteriorly, with irrigation and wound vac placement.On (b)(6) 2019, it was noted that the wound vac was not functioning.The next day, the patient underwent revision amputation of the infected necrotic lesion by repeat irrigation and debridement.On (b)(6) 2019, the patient was found to be in stable condition and was discharged to a rehabilitation hospital.At the rehab stay, the patient was noted to be acute of chronic anemia.On (b)(6) 2019, the patient was discharged home from the rehabilitation center with dual anti-platelet therapy.

• 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: 8227936
• MDR Text Key: 132415486
• Report Number: 2134265-2018-64657
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 0018389831
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR