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 Vascular Dissection (3160); Thrombosis/Thrombus (4440)

Event Date 02/03/2023

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).Age at time of event: the patient was 59 years old at the time of study enrollment.

Event Description

S2444 elegance clinical study.It was reported that thrombosis and dissection occurred during the index procedure.On (b)(6) 2023, the subject underwent treatment with eluvia drug-eluting stent and ranger drug coated balloons as a part of the elegance clinical trial.The target lesion #001 was in the right proximal superficial femoral artery 9sfa) extending into right mid sfa with proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 7 mm with lesion length of 40 mm and 70% stenosis and was classified as tasc ii a lesion.Treatment of target lesion was performed by study devices, 7 mm x 60 mm eluvia drug-eluting stent and 6 mm x 40 mm ranger drug-coated balloon.Following post dilation with a non-bsc balloon was performed, the final residual stenosis was noted to be 30%.The target lesion #002 was in the right common femoral artery with proximal reference vessel diameter of 7 mm and distal reference vessel diameter of 7 mm with lesion length of 60 mm and 80% stenosis and was classified as tasc ii b lesion.Treatment of target lesion was performed by study device, 7 mm x 60 mm ranger drug-coated balloon.Following treatment, the final residual stenosis was noted to be 30%.On the same day of index procedure, during the treatment of target lesions right proximal sfa and right mid sfa, dissection of grade a and thrombosis were noted and in right common femoral artery.Per target lesions 001 and 002, balloon dilation and bailout stent were performed to treat dissection and thrombosis noted.In addition, medication was given, angiography and thrombectomy were also performed.No further patient consequences were reported.

Manufacturer Narrative

A1 - patient identifier: (b)(6).A2 - age at time of event: the patient was 59 years old at the time of study enrollment.Updated fields: b5 - additional information was received that confirmed the originally reported event of thrombosis was not related to the complaint device.Thus, the event summary has been updated accordingly.G1 - mfr contact first name, mfr contact last name, mfr contact phone number, mfr contact email.H6 - removal of thrombosis/thrombus e0514; updated evaluation method codes, evaluation result codes, and evaluation conclusion codes.

Event Description

S2444 elegance clinical study.It was reported that thrombosis and dissection occurred during the index procedure.On (b)(6) 2023, the subject underwent treatment with eluvia drug-eluting stent and ranger drug coated balloons as a part of the elegance clinical trial.The target lesion #001 was in the right proximal superficial femoral artery 9sfa) extending into right mid sfa with proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 7 mm with lesion length of 40 mm and 70% stenosis and was classified as tasc ii a lesion.Treatment of target lesion was performed by study devices, 7 mm x 60 mm eluvia drug-eluting stent and 6 mm x 40 mm ranger drug-coated balloon.Following post dilation with a non-bsc balloon was performed, the final residual stenosis was noted to be 30%.The target lesion #002 was in the right common femoral artery with proximal reference vessel diameter of 7 mm and distal reference vessel diameter of 7 mm with lesion length of 60 mm and 80% stenosis and was classified as tasc ii b lesion.Treatment of target lesion was performed by study device, 7 mm x 60 mm ranger drug-coated balloon.Following treatment, the final residual stenosis was noted to be 30%.On the same day of index procedure, during the treatment of target lesions right proximal sfa and right mid sfa, dissection of grade a and thrombosis were noted and in right common femoral artery.Per target lesions 001 and 002, balloon dilation and bailout stent were performed to treat dissection and thrombosis noted.In addition, medication was given, angiography and thrombectomy were also performed.No further patient consequences were reported.It was further reported that the thrombosis that occurred on (b)(6) 2023, was not related to the study device or study procedure.

• 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: 16468653
• MDR Text Key: 310523369
• Report Number: 2124215-2023-09313
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876694
• UDI-Public: 08714729876694
• 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: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2024
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0029410109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RANGER PACLITAXEL COATED PTA BALLOON CATHETER; RANGER PACLITAXEL COATED PTA BALLOON CATHETER; RANGER PACLITAXEL COATED PTA BALLOON CATHETER; RANGER PACLITAXEL COATED PTA BALLOON CATHETER
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Race: White