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

Model Number 24657

Device Problem Activation Failure (3270)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/07/2023

Event Type  Injury  

Manufacturer Narrative

A1 - patient identifier: (b)(6).A2 - age at time of event: the patient was 73 years old at the time of study enrollment.

Event Description

(b)(4).It was reported that the subject experienced stent thrombosis and stent under expansion during the index procedure.The subject underwent treatment with the eluvia drug-eluting stents and ranger drug-coated balloon on (b)(6) 2023 as a part of the (b)(4) clinical trial.The target lesion (001) was in the left proximal superficial femoral artery (sfa), left mid sfa, left distal sfa, left proximal popliteal artery, extending up to left mid popliteal artery.The target lesion had a 5.5 mm distal reference vessel diameter with 70% stenosis and was classified as tasc ii d lesion.Prior to the treatment of target lesion with the study device, pre-dilation was performed by using 4 mm x 220 mm and 6 mm x 120 mm sterling over the wire pta balloon.Treatment of target lesion was performed by dilation using study devices, placement of two 7 mm x 120 mm, one 7 mm x 60 mm, and one 7 mm x 80 mm eluvia drug-eluting stents, followed by 6 mm x 120 mm ranger drug-coated balloon angioplasty.Following which, post-treatment was performed with placement of a 7 mm x 250 mm non-boston scientific stent and balloon dilation was performed by using a 6 mm x 60 mm non-boston scientific balloon, 7 mm x 80 mm sterling over the wire pta balloon, and 7 mm mustang balloon.Post treatment, the final residual stenosis was noted to be 30%.During the treatment of target lesion (001), angiography performed revealed under expansion of the 7 mm x 120 mm eluvia drug eluting stent, placed in the left sfa.Following which, the stent was extended to endarterectomized portion of left sfa with 7 mm x 120 mm and 7 mm x 60 mm eluvia drug eluting stents in an overlapping manner.Subsequently, the under expanded stent was treated with balloon dilation using 7 mm x 80 mm sterling balloon, however, angiography revealed sluggish flow through sfa stent.Hence, attempt was made to expand the stent with lithotripsy using an unknown 6 mm x 60 mm balloon.Angiography performed revealed flow limiting dissection which was treated with placement of 7 mm x 80 mm eluvia stent.Post procedural angiography performed revealed under expanded eluvia drug eluting stent and possible thrombus in the stent placed in the left sfa.In response to the event, a non-boston scientific stent was deployed from above knee popliteal artery to the proximal sfa.Following which, aggressive angioplasty was performed to treat the under expanded stent with 7 mm mustang balloon which resulted in the full expansion of the sfa stent.Angiography performed revealed sluggish flow in the sfa stent with no evidence of residual stenosis or thrombus.On (b)(6) 2023, the subject was discharged from the hospital.

Manufacturer Narrative

A1 - patient identifier: (b)(6).A2 - age at time of event: the patient was 73 years old at the time of study enrollment.Updated fields: b5 - describe event or problem.B6 - relevant tests/laboratory data.B7 - other relevant history.

Event Description

(b)(4) elegance it was reported that the subject experienced stent thrombosis and stent under expansion during the index procedure.The subject underwent treatment with the eluvia drug-eluting stents and ranger drug-coated balloon on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion (001) was in the left proximal superficial femoral artery (sfa), left mid sfa, left distal sfa, left proximal popliteal artery, extending up to left mid popliteal artery.The target lesion had a 5.5 mm distal reference vessel diameter with 70% stenosis and was classified as tasc ii d lesion.Prior to the treatment of target lesion with the study device, pre-dilation was performed by using 4 mm x 220 mm and 6 mm x 120 mm sterling over the wire pta balloon.Treatment of target lesion was performed by dilation using study devices, placement of two 7 mm x 120 mm, one 7 mm x 60 mm, and one 7 mm x 80 mm eluvia drug-eluting stents, followed by 6 mm x 120 mm ranger drug-coated balloon angioplasty.Following which, post-treatment was performed with placement of a 7 mm x 250 mm non-boston scientific stent and balloon dilation was performed by using a 6 mm x 60 mm non-boston scientific balloon, 7 mm x 80 mm sterling over the wire pta balloon, and 7 mm mustang balloon.Post treatment, the final residual stenosis was noted to be 30%.During the treatment of target lesion (001), angiography performed revealed under expansion of the 7 mm x 120 mm eluvia drug eluting stent, placed in the left sfa.Following which, the stent was extended to endarterectomized portion of left sfa with 7 mm x 120 mm and 7 mm x 60 mm eluvia drug eluting stents in an overlapping manner.Subsequently, the under expanded stent was treated with balloon dilation using 7 mm x 80 mm sterling balloon, however, angiography revealed sluggish flow through sfa stent.Hence, attempt was made to expand the stent with lithotripsy using an unknown 6 mm x 60 mm balloon.Angiography performed revealed flow limiting dissection which was treated with placement of 7 mm x 80 mm eluvia stent.Post procedural angiography performed revealed under expanded eluvia drug eluting stent and possible thrombus in the stent placed in the left sfa.In response to the event, a non-boston scientific stent was deployed from above knee popliteal artery to the proximal sfa.Following which, aggressive angioplasty was performed to treat the under expanded stent with 7 mm mustang balloon which resulted in the full expansion of the sfa stent.Angiography performed revealed sluggish flow in the sfa stent with no evidence of residual stenosis or thrombus.On (b)(6) 2023, the subject was discharged from the hospital.It was further reported that the target lesion had a proximal reference vessel diameter of 6.5 mm and a lesion length of 250 mm.On (b)(6) 2023 during the index procedure, occlusion noted in the left common femoral artery and sfa were treated with endarterectomy followed by pre-dilation of sfa and popliteal artery using 4mm x 220 mm sterling pta and angioplasty of left sfa with 6mm x 120 mm sterling balloon.Due to extensive calcific disease and multiple dissection planes, 7mm x 120 mm eluvia stent was placed from left distal sfa to proximal sfa.The previously reported flow-limiting dissection was further reported to be grade e in the left above knee popliteal artery, and was attributed to the 6mm x 120mm sterling balloon.Post procedure, angiography performed revealed filling defect with possible thrombus in the mid segment of left sfa stent.

• 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: 17842992
• MDR Text Key: 324577277
• Report Number: 2124215-2023-53203
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0031481708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Race: Black Or African American