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 Obstruction/Occlusion (2422); Vascular Dissection (3160)

Event Date 07/26/2023

Event Type  Injury  

Event Description

It was reported that an occlusion and dissections occurred.On (b)(6) 2023, blood has drawn in the holding area and a chem 8 was performed to evaluate the patient's renal function.The creatinine was 1.0.After counseling the patient for the procedure, the patient was taken to the fluoroscopy suite and placed in the supine position.The bilateral groins were prepped end draped in the usual manner.Monitored moderate sedation was instituted with iv versed and fentanyl.Ultrasound guidance for vascular access was used to document vessel patency with concurrent ultrasound visualization of vascular needle entry with permanent recording and reporting of vessel patency.Under ultrasound guidance, the skin and soft tissues over the left common femoral artery were infiltrated with 1% lidocaine.Under ultrasound guidance, the left common femoral artery was accessed with micropuncture needle and wire.A micropuncture sheath was advanced over the wire.The wire was upsized to an 035 non boston scientific wire which was advanced into the abdominal aorta under fluoroscopic guidance.A sheath exchange was then performed, placing a 5 french short sheath.A flush catheter was then advanced over the wire and placed at the l2 level.Power injection was then used to obtain an abdominal aortogram.This showed an eccentric plaque in the distal abdominal aorta causing approximately 40% stenosis.The aortic bifurcation is heavily calcified.There is approximately 40 to 50% bilateral common iliac artery stenosis.The right common iliac artery was then selected with the flush catheter and a non boston scientific wire.The wire was advanced down to the right external iliac artery level.The flush catheter would not advance; therefore, catheter exchange was performed, placing an 035 rubicon crossing catheter.The catheter was advanced down to the distal external iliac artery level.The wire was removed, and a right lower extremity arteriogram was obtained in a stepwise fashion by catheter injection.This showed an eccentric plaque in the common femoral artery causing approximately 50% stenosis.The profunda femoral artery is widely patent.The proximal superficial femoral artery is patent.The superficial femoral artery displays multiple areas of high-grade preocclusive stenosis in its midportion.It occluded in the distal thigh.There is reconstitution at hunters canal.The popliteal artery is widely patent.There is three-vessel runoff.Preparation for sheath exchange, a non boston scientific wire was advanced into the right common femoral artery.A sheath exchange was attempted, placing 7 french 46 cm sheath.However, the sheath tip would not cross the aortic bifurcation.Therefore, the rubicon catheter was replaced, and attempted to advance an amplatz wire over the bifurcation.However, it would not advance past the bifurcation: the rubicon catheter was suspected to be kinked.An attempt to advance a non boston scientific wire past this area but was unable to.Upon removing the non boston scientific wire it was noticed that part of the plastic tip was missing.The rubicon catheter was removed and examined.There indeed was kink in a hole in the catheter.The catheter tip was not seen.A non boston scientific catheter and new non boston scientific wire were advanced down to the right common femoral artery level.An amplatz wire was then advanced into the right common femoral artery.The sheath was able to be advances over the non boston scientific catheter and amplatz wire until its tip was in the distal external iliac artery.A new rubicon crossing catheter was then advanced over the wire.A wire exchange was performed placing a non boston scientific wire.The non boston scientific wire and catheter were advanced relatively easily through the superficial femoral artery (sfa) into the below-knee popliteal artery.Intraluminal position was confirmed by catheter injection.An.009 wire was then advanced into the below-knee popliteal artery.Atherectomy of the common femoral and superficial femoral arteries was then performed with a rotablator 2.5 mm atherectomy device.The atherectomy device was activated while wire position was monitored.Rpms and advanced the atherectomy catheter.Balloon angioplasty was then performed to the superficial femoral and common femoral arteries with a 5 x 200 mm balloon utilizing 3 overlapping inflations each held for 3 minutes.Repeat imaging through the sheath showed an excellent result with the exception of a linear filling defect in the mid sfa.Upon close inspection, it was suspected that this was the tip of the non boston scientific wire.An 6x40,130cm eluvia drug-eluting vascular stent system was centered over the defect and deployed in standard fashion.Repeat imaging through the sheath showed an excellent result.The wire tip is no longer visualized and assumed to be trapped behind the stent.The runoff is maintained.Satisfied with the result, a 7 french non boston scientific percutaneous closure device was deployed in the left common femoral artery in standard fashion which resulted in excellent hemostasis.A dressing was placed.The patient tolerated the procedure well and was taken to the recovery area in good condition.On (b)(6) 2023, blood has drawn in the holding area and a chem 8 was performed to evaluate the patient's renal function.The creatinine was 1.2.After counseling the patient for the procedure, the patient was taken to the fluoroscopy suite and placed in the supine position.The bilateral groins were prepped end draped in the usual manner.Monitored moderate sedation was instituted with iv versed and fentanyl.Ultrasound guidance for vascular access was used to document vessel patency with concurrent ultrasound visualization of vascular needle entry with permanent recording and reporting of vessel patency.Under ultrasound guidance, the skin and soft tissues over the left common femoral artery were infiltrated with 1% lidocaine.Under ultrasound guidance, the left common femoral artery was accessed with micropuncture needle and wire.A micropuncture sheath was advanced over the wire.The wire was upsized to an 035 non boston scientific wire which was advanced into the abdominal aorta under fluoroscopic guidance.A sheath exchange was then performed, placing a 5 french short sheath.A flush catheter was then advanced over the wire and placed at the abdominal aorta.The right common iliac artery was then selected with the flush catheter and non boston scientific wire.The wire and catheter were advanced down to the right common femoral artery level.The wire was removed, and a right lower extremity arteriogram was obtained in a stepwise fashion by catheter injection.This showed the common and profunda femoral arteries to be widely patent.The superficial femoral artery occludes shortly distal to its origin.The indwelling stent in the mid sfa is occluded.The sfa reconstitutes in the distal thigh.The pc popliteal artery is widely patent.There is three-vessel runoff.In preparation for sheath exchange, a non boston scientific wire was advanced into the proximal sfa.A sheath exchange was performed, placing a 6 french 45 cm sheath with its tip in the right common femoral artery.The patient then systemically heparinized.A non boston scientific wire and rubicon crossing catheter were then advanced through the occluded sfa into the popliteal.Intraluminal position in the popliteal was confirmed by catheter injection.A 5 mm non boston scientific embolic protection device was then deployed in the popliteal artery at the level of the knee joint.Atherectomy of the sfa was then performed with a 6 french non boston scientific atherectomy device.The atherectomy device was activated, wire position was maintained and aspiration flow was monitored while the atherectomy catheter was advanced.2 passes were taken.Repeat imaging showed a patent but small flow lumen.Balloon angioplasty of the sfa was then performed with a 5 x 200 mm balloon utilizing 2 overlapping inflations each held for 3 minutes.Repeat imaging showed significant dissections proximally and distally, therefore, an.035 wire was placed down in the popliteal.Each area of dissection was treated with a 4 to 8 mm non boston scientific stent deployed in standard fashion.Repeat imaging showed an excellent result with no significant residual stenosis, no visualized dissections, brisk flow and preserved runoff.Satisfied with the result, a 6 french non boston scientific percutaneous closure device was deployed in the left common femoral artery in standard fashion which resulted in excellent hemostasis.A dressing was placed.The patient tolerated the procedure well and was taken to the recovery area in good condition.

• 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: 17597137
• MDR Text Key: 321667931
• Report Number: 2124215-2023-44924
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876571
• UDI-Public: 08714729876571
• 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: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• 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: 0030206227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female