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

Model Number 24657

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

Patient Problems Ischemia (1942); Pain (1994); Unspecified Vascular Problem (4441)

Event Date 10/29/2022

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).

Event Description

It was reported that the patient experienced right lower extremity critical limb ischemia, resulting in right leg above the knee amputation 216 days post index procedure.On (b)(6) 2022, the patient underwent treatment for peripheral artery disease (pad) with two eluvia drug-eluting stents and a ranger drug coated balloon as a part of the elegance clinical trial.The target lesion was located in the right distal superficial femoral artery (sfa) extending into the right proximal popliteal artery.The target lesion had a proximal reference vessel diameter of 6.0 mm and distal reference vessel diameter of 6.0 mm with lesion length of 400 mm.The vessel was 100% stenosed and was classified as tasc ii b lesion.Prior to target lesion treatment with the study devices, pre-dilatation was performed using a 5 mm x 200 mm non-bsc balloon and a 5 mm x 80 mm non-bsc balloon and placement of a 7 mm x 150 mm non-bsc metal stent.Treatment of the target lesion was performed by placement using study devices of size 5 mm x 200 mm ranger drug coated balloon and two eluvia drug-eluting stents of size 7 mm x 120 mm.Following stent placement, post-dilatation was performed using a 5 mm x 80 mm non-bsc balloon.The final residual stenosis was noted to be 5%.It was additionally reported that 80% dense calcific stenosis was noted in the right external iliac artery.The stenosed area of the right external iliac artery was pre-dilated using an unknown 7 mm balloon, followed by placement of a 10 mm x 60 mm non-bsc stent.Following stent placement, the non-bsc stent was post-dilated using an unknown 7 mm balloon to high pressure to achieve excellent angiographic result.The patient was discharged from the hospital on aspirin and clopidogrel.On (b)(6) 2022, the patient underwent resection of the right 5th metatarsal due to osteomyelitis and continued to have nonhealing wounds on the right foot.Due to the stents in his right lower extremity, it resulted in partial occlusion in the profunda artery which was planned to be treated by right femoral popliteal bypass surgery on (b)(6) 2022, but was cancelled due to emergent circumstances.The patient underwent a ct angiogram which revealed the following: in the right leg: 50 percent stenosis in the right common femoral artery; occlusion of the mid to distal portion of the stent in right proximal sfa; occlusion of right mid and distal sfa with probable collateral flow; greater than 90 percent stenosis in the right popliteal artery; 50 percent stenosis of the tibio-peroneal trunk; and several foci of 50 percent stenoses within the right posterior tibial and right anterior tibial arteries.In the left leg: greater than 90 percent stenosis in the left common femoral artery; several foci of 50-75 percent stenosis in the left sfa; 50 percent stenosis of the left popliteal artery; and several foci of 50 percent stenoses within the posterior tibial artery.On (b)(6) 2022, the patient presented to the emergency department with symptoms of nausea, vomiting, and diarrhea for three days, as well as worsening right lower extremity pain, ankle swelling, and ascending erythema.The patient was transferred to another hospital.Physical examination of the patient revealed: right foot edema, erythema, loss of sensation, open wound on lateral aspect of foot without resultant expression of fluid or purulence, eschar draping over right heel and lateral aspect of the right foot which extended to the plantar aspect of the foot.Digit 5 had been previously amputated on (b)(6) 2022.The toes were dusky in color with tips of digits 2, 3, and 4 presenting purple discoloration.The right foot had no dopplerable signals on dorsalis pedis (dp) and posterior tibial (pt).On (b)(6) 2022, the subject was admitted to the hospital to treat acute kidney injury (aki), increased anion gap metabolic acidosis, and other conditions.On (b)(6) 2022, 216 days post index procedure, the patient underwent right leg above the knee amputation.Subsequently, the patient was noted with hyperkalemia.As a result of this condition, aldactone and ace-inhibitor were discontinued, and the patient was started on a low-potassium diet.In addition, the patient was given iv lasix, which did improve the potassium levels and oral lasix was resumed.During the course of hospitalization, subjects aki and metabolic acidosis were resolved with iv fluids.On (b)(6) 2022, the patient was discharged from the hospital with plavix.On the day of discharge, the patient reported right lower extremity pain that radiated to his groin and right lower abdomen without any swelling, tenderness, or edema.No additional patient complications were reported.

Manufacturer Narrative

A1 - patient identifier: (b)(6).

Event Description

Elegance (b)(6).It was reported that the patient experienced right lower extremity critical limb ischemia, resulting in right leg above the knee amputation 216 days post index procedure.On (b)(6) 2022, the patient underwent treatment for peripheral artery disease (pad) with two eluvia drug-eluting stents and a ranger drug coated balloon as a part of the elegance clinical trial.The target lesion was located in the right distal superficial femoral artery (sfa) extending into the right proximal popliteal artery.The target lesion had a proximal reference vessel diameter of 6.0 mm and distal reference vessel diameter of 6.0 mm with lesion length of 400 mm.The vessel was 100% stenosed and was classified as tasc ii b lesion.Prior to target lesion treatment with the study devices, pre-dilatation was performed using a 5 mm x 200 mm non-bsc balloon and a 5 mm x 80 mm non-bsc balloon and placement of a 7 mm x 150 mm non-bsc metal stent.Treatment of the target lesion was performed by placement using study devices of size 5 mm x 200 mm ranger drug coated balloon and two eluvia drug-eluting stents of size 7 mm x 120 mm.Following stent placement, post-dilatation was performed using a 5 mm x 80 mm non-bsc balloon.The final residual stenosis was noted to be 5%.It was additionally reported that 80% dense calcific stenosis was noted in the right external iliac artery.The stenosed area of the right external iliac artery was pre-dilated using an unknown 7 mm balloon, followed by placement of a 10 mm x 60 mm non-bsc stent.Following stent placement, the non-bsc stent was post-dilated using an unknown 7 mm balloon to high pressure to achieve excellent angiographic result.The patient was discharged from the hospital on aspirin and clopidogrel.On (b)(6) 2022, the patient underwent resection of the right 5th metatarsal due to osteomyelitis and continued to have nonhealing wounds on the right foot.Due to the stents in his right lower extremity, it resulted in partial occlusion in the profunda artery which was planned to be treated by right femoral popliteal bypass surgery on (b)(6) 2022, but was cancelled due to emergent circumstances.The patient underwent a ct angiogram which revealed the following: in the right leg: 50 percent stenosis in the right common femoral artery; occlusion of the mid to distal portion of the stent in right proximal sfa; occlusion of right mid and distal sfa with probable collateral flow; greater than 90 percent stenosis in the right popliteal artery; 50 percent stenosis of the tibio-peroneal trunk; and several foci of 50 percent stenoses within the right posterior tibial and right anterior tibial arteries.In the left leg: greater than 90 percent stenosis in the left common femoral artery; several foci of 50-75 percent stenosis in the left sfa; 50 percent stenosis of the left popliteal artery; and several foci of 50 percent stenoses within the posterior tibial artery.On (b)(6) 2022, the patient presented to the emergency department with symptoms of nausea, vomiting, and diarrhea for three days, as well as worsening right lower extremity pain, ankle swelling, and ascending erythema.The patient was transferred to another hospital.Physical examination of the patient revealed: right foot edema, erythema, loss of sensation, open wound on lateral aspect of foot without resultant expression of fluid or purulence, eschar draping over right heel and lateral aspect of the right foot which extended to the plantar aspect of the foot.Digit 5 had been previously amputated on (b)(6) 2022.The toes were dusky in color with tips of digits 2, 3, and 4 presenting purple discoloration.The right foot had no dopplerable signals on dorsalis pedis (dp) and posterior tibial (pt).On (b)(6) 2022, the subject was admitted to the hospital to treat acute kidney injury (aki), increased anion gap metabolic acidosis, and other conditions.On (b)(6) 2022, 216 days post index procedure, the patient underwent right leg above the knee amputation.Subsequently, the patient was noted with hyperkalemia.As a result of this condition, aldactone and ace-inhibitor were discontinued, and the patient was started on a low-potassium diet.In addition, the patient was given iv lasix, which did improve the potassium levels and oral lasix was resumed.During the course of hospitalization, aki and metabolic acidosis were resolved with iv fluids.On (b)(6) 2022, the patient was discharged from the hospital with plavix.On the day of discharge, the patient reported right lower extremity pain that radiated to his groin and right lower abdomen without any swelling, tenderness, or edema.No additional patient complications were reported.It was further reported that on january 03, 2023, the event was considered to be resolved with sequelae.

• Brand Name: ELUVIA 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; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15904745
• MDR Text Key: 304691899
• Report Number: 2124215-2022-47767
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876731
• UDI-Public: 08714729876731
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0028055736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Race: White