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 Pain (1994); Vasoconstriction (2126); Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437)

Event Date 11/09/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced incapacitation claudication of the left leg as a result of in-stent reocclusion.An eluvia drug-eluting vascular stent system was selected for use to treat a case of peripheral vascular disease with bilateral lower extremity claudication.With the patient in the supine position on fluoroscopic table, both groins were prepped and draped in usual fashion.1% xylocaine without epinephrine was used for local infiltrative anesthesia.Patient was given versed and fentanyl intravenously in small increments through the course of the procedure for comfort.The patient was also given intra-arterial nitroglycerin through the course of the procedure for hypertension and to prevent vasospasm.The patient was given hydralazine also for hypertension.The site right ultrasound was used for real-time imaging for needle entry into the right common femoral artery with photographic documentation.A 21-gauge micro puncture needle was used, and a 0.018 wire was passed followed by a 4 french introducer.A j-wire was passed to the suprarenal aorta and a 5 french sheath was placed.A non-boston scientific catheter was passed to the level of l1 and abdominal aortogram was performed.This showed the mesenteric and renal vessels to be widely patent and the abdominal aorta was widely patent.The catheter was pulled down to the lower abdominal aorta where bilateral lower extremity arteriogram was performed.This showed both common iliac, both hypogastric and both external iliac arteries to be widely patent.The left common iliac artery was selectively catheterized, and the catheter was advanced to the distal external iliac artery.Selective left lower extremity arteriogram was then performed.This slowed a high-grade stenosis in the left common femoral artery with a flush occlusion of the superficial femoral artery.This continued to just below hunter's canal where there was reconstitution of the popliteal artery.The above-knee and below-knee popliteal artery appeared normal.The patient was given 10,000 units of heparin intravenously and 1 hour later a second dose of heparin 1500 units and 1 hour after this the third dose 1500 units for total doge of 13,000 units during the course of the procedure.A 6 x 45 sheath was advance to the distal left external iliac artery.Using a 0.035 glidewire and rubicon catheter, the physician was able to engage the occlusion of the sfa and advance to the mid-thigh; however, the physician was unable to get back into the true lumen.At this point, retrograde puncture initially of the posterior tibial artery was attempted but despite entering the vessel several times, the physician was unable to get the wire to thread.Ultimately using the dorsalis pedis artery, the physician was able to successfully puncture the dorsal pedal artery and passed the wire followed by the inner core of the 4 french introducer and arteriogram confirmed intra-arterial location with widely patent vessel.A v-18 wire was then passed and a 0.018 rubicon support catheter used to pass to the mid-thigh from below, but the physician was unable to get back into the true lumen.Proceeded with balloon angioplasty using a 5 x 4 balloon from above and a 3 x 6 balloon from below, with the tips of each balloon touching in the mid sfa.The balloons were simultaneously inflated, held for one minute, deflated, and then removed.Following this, successfully passed the v-18 wire proximally into a burn catheter which had been passed down from above to capture the wire and remove it out the right femoral sheath.The 0.018 rubicon was passed from the right groin down into the anterior tibial and dorsalis pedis arteries.The access in the dorsalis pedis was maintained with the inner core and a 0.009 wire was advanced into the distal anterior tibial and dorsalis pedis beyond the puncture site.A rotablator atherectomy device with 2.0 mm was selected due to the complex nature of the procedure.The rotablator burr was intermittently advanced.Following this, repeat angiogram showed a nice channel but with irregularity through hunter's canal.A 5 x 200 balloon was then used to dilate the entire length of the sfa and the proximal popliteal artery, with each inflation being taken to nominal pressure, complete expansion obtained.Each inflation was held for 3 minutes, deflated, and then removed.Repeat angiogram showed persistent dissection through hunter's canal.The physician elected to proceed with placement of a 6 x 60 drug-coated eluvia stent.The stent was deployed in excellent position and then post dilated with the 5 mm balloon.Repeat angiogram showed wide patency through the sfa with brisk flow distally.Attention was then turned to the distal anterior tibial and dorsalis pedis artery.The wire was then exchanged for the v-18 and the 3 x 6 balloon was advanced down into the dorsalis pedis and in the distal anterior tibial artery.The access site inner core was removed.The balloon was inflated, and the inflation was held for a full 5 minutes, deflated, and then removed.Repeat angiogram showed wide patency of the anterior tibial artery with no evidence of any extravasation.These findings were accepted.The sheath and guidewire were removed, a star close device was deployed at the right femoral puncture site with excellent hemostasis and the patient was taken to the recovery area in stable condition.She tolerated the procedure well.The patient presented with new incapacitating claudication affecting her left leg where she can only walk a very short distance without severe pain.Ultrasound showed re-occlusion of her sfa, so she was brought in for arteriogram for further evaluation and possible intervention.On november 09, 2023, with the patient in the supine position on fluoroscopic table, both groins were prepped and draped in usual fashion.1% xylocaine with epinephrine was used for local infiltrative anesthesia.The patient was given versed end fentanyl intravenously in small increments through the course of the procedure for comfort.The patient was given hydralazine intravenously for hypertension and nitroglycerin intra-arterially to prevent vasospasm and to treat hypertension.The site right ultrasound was used for real-time imaging for needle entry into the right common femoral artery with photographic documentation.A 20-gauge micro puncture needle was used, and a 0.018 wire passed followed by a 4 french introducer.A j-wire was passed to the aorta and a 5 french sheath was placed.An omni flush catheter was passed to the aortic bifurcation.Aortogram and bilateral lower extremity arteriogram were not repeated as this was done approximately 2 months ago and were normal at that time.The left common iliac artery was selectively catheterized, and the catheter was advanced to the left common femoral artery.Selective left lower extremity arteriogram was then performed.This showed the common femoral and profunda femoral to be patent.The sfa had flush occlusion at the origin with total occlusion through a previously placed stent and reconstitution below hunter's canal in the distal above-knee popliteal artery.The below-knee popliteal artery was patent.The patient was given 10,000 units of heparin intravenously and each hour thereafter 1500 units for total doge of 13,000 units during the course of the procedure.A 7 x 45 sheath was advance to the left common femoral artery.Using a 0.035 glidewire and rubicon catheter, the occlusion in the sfa was engaged and gradually advance to the mid sfa and the previously placed stent.Angiogram from the sfa showed the vessel to be totally occluded but not a lot of clot was seen in the stent itself.Advanced to below the stent and angiogram from the popliteal artery showed the location to be a branch with a focal dissection, so the catheter was pulled back.Despite multiple efforts, the physician was unable to enter the true lumen.At this point, it was felt that retrograde puncture distally would be the only feasible way to cross this.The left foot and lower leg were prepped and again the site right ultrasound was used for real-time imaging for needle entry into the left posterior tibial artery.Attempt was made for the anterior tibial and distal dorsalis pedis, but the vessel was simply too small to puncture.Successfully punctured the posterior tibial artery and a 0.018 wire passed followed by the inner core of the 4 french introducer.Arteriogram from the posterior tibial artery showed 3 vessel runoff throughout in the lower leg and no high-grade obstructions.The patient did have some significant vasospasm for which nitroglycerin was given liberally.We are able to advance retrograde to the popliteal and advance true lumen through the area of the previous dissection up into the occluded stent.We were then able to pass up into the superficial femoral artery above this where we capture the foreign body and exteriorized it out of the left femoral sheath.The catheter was then removed and passed from above to the left common femoral, left popliteal and into the posterior tibial artery at the ankle.A 0.009 wire was advanced into the distal posterior tibial artery at the ankle below the puncture site.A rotablator atherectomy device with a 2.5 mm burr was selected.The rotablator burr was intermittently advanced.The entire length of the sfa and popliteal artery were treated to below the knee joint.This was done without complication.The wire was then exchanged for a v-18 and a 5 x 200 balloon was used to dilate the entire length of the above-knee, the entire length of the sfa, and the entire length of the common femoral artery.Each inflation was taken to nominal pressure with multiple ways noted but complete expansion obtained.Each inflation was held for 3 minutes, deflated, and then removed.Repeat angiogram showed the upper portion of the sfa to be widely patent and the previously placed stent was widely patent.Below the stent there was significant dissection and irregularity so a 6 x 1 20 drug-coated eluvia stent was selected.This was allowed to overlap by one cm the previously placed stent down to just above the knee joint.The stent was then post dilated with the 5 x 200 balloon.Repeat angiogram showed wide patency to the superficial femoral and popliteal arteries.Runoff films showed significant vasospasm in the posterior tibial artery so a 3 x 2 20 balloon was selected and passed down to below the ankle.The balloon was inflated and just prior to this the inner core of the 4 french introducer was removed.Inflation was held for 5 minutes, deflated, and then repositioned.After the entire length of the posterior tibial had been balloon dilated and generous amount of nitroglycerin given repeat angiogram showed resolution of the spasm with brisk flow seen distally.These findings were accepted.The sheath was removed.A star close device deployed at the puncture site; direct pressure held, and excellent hemostasis was obtained.The patient was taken to the recovery area in stable condition.She tolerated the procedure well.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18246862
• MDR Text Key: 329488847
• Report Number: 2124215-2023-68025
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876588
• UDI-Public: 08714729876588
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0030429479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 0.035 GLIDEWIRE; ROTABLATOR; RUBICON; V-18 WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Race: White