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 Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 02/20/2023

Event Type  Injury  

Event Description

It was reported that in-stent restenosis and thrombosis occurred.On (b)(6) 2022, selective right lower extremity arteriogram, atherectomy, and balloon angioplasty of the right superficial femoral, popliteal, tibioperoneal trunk, and anterior tibial arteries were performed, which included stenting of the right superficial femoral artery (sfa).The patient had right left leg ischemia.During the procedure, a 6x120mm eluvia drug-eluting stent was deployed in standard fashion in the distal sfa.It was post-dilated with a 5x150mm balloon.Final imaging showed an excellent result with no residual stenosis and brisk flow to the foot.The patient tolerated the procedure well and was taken to the recovery area in good condition.On (b)(6) 2023, aortogram, selective right lower extremity arteriogram, balloon angioplasty of right popliteal artery, and lysis catheter placement were performed to treat peripheral artery disease and acute limb ischemia.During the procedure, it was observed that the sfa was occluded in the mid thigh just above the previously placed eluvia stent.The stent was occluded.A non-boston scientific guidewire and 035 rubicon crossing catheter were advance into the occluded sfa.The wire and catheter advanced relatively easily through the occluded sfa, suggesting the presence of relatively fresh thrombus.There was difficulty advancing the wire and catheter at the level of the above-knee popliteal.Therefore, the physician downsized to a v18 wire and 018 rubicon catheter.The wire and catheter were able to be advanced into the anterior tibial artery.Intraluminal position in the anterior tibial was confirmed by catheter injection.Given the physician's suspicion for significant thrombus, the physician decided to place a lysis catheter.A 4f non-boston scientific infusion catheter with a 50cm infusion length was advanced over the wire.However, at the level of the popliteal artery just above the knee joint, resistance was felt, and the catheter was unable to be advanced further.A tight atherosclerotic lesion was suspected at this level.Therefore, balloon angioplasty was performed.A 3x100mm balloon was advanced over the wire and inflated at this level for 3 minutes.The non-boston scientific infusion catheter was then able to be advanced into the proximal anterior tibial.The catheter was packed with 2mg of tpa.The patient tolerated the procedure well and was taken to the recovery area to await ambulance transport to the hospital for inpatient catheter directed thrombolysis.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16649195
• MDR Text Key: 312398889
• Report Number: 2124215-2023-14963
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876618
• UDI-Public: 08714729876618
• 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: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0028397662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female