MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA; STENT, SUPERFICIAL FEMORAL ARTERY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/10/2022

Event Type  Injury  

Manufacturer Narrative

A1: patient identifier- (b)(6).A2: patient age at time of enrollment- 62 years old.

Event Description

Elegance study.It was reported that an occlusion occurred, requiring additional intervention and device.The subject underwent treatment with the ranger drug coated balloon on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the right distal superficial femoral artery, right proximal popliteal artery, right mid popliteal artery extending into right distal popliteal artery with proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm with lesion length of 150 mm and 100% stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment, balloon dilatation was performed using 3.0 mm x 100 mm coyote pta balloon.The treatment of target lesion was performed by dilatation using study device 6 mm x 200 mm ranger drug coated balloon.Following post treatment stent was placed with 6.0 mm x 130 mm innova bare metal stent and the final residual stenosis was noted to be 5%.On the same day, the subject was discharged on dual antiplatelet therapy.Per edc, on (b)(6) 2022, the subject was noted with the symptoms related to occlusion of distal right sfa and popliteal artery.Per source, on the same day, pvl arterial duplex right lower extremity revealed occlusion through right mid sfa to distal sfa and stented right popliteal artery.On (b)(6) 2022, abi was noted as 0.32 (0.73) and rle arterial duplex revealed occlusion of the right mid to distal sfa.On (b)(6) 2022, 265 days post index procedure, 100% stenosis noted in distal sfa, proximal popliteal artery, mid popliteal artery and distal popliteal artery were treated by percutaneous transluminal angioplasty, drug eluting stent and stent-graft placement.Final residual stenosis was noted to be 5%.Per source, on the same day, ivus evaluation of right tibioperoneal trunk, popliteal artery, superficial femoral artery was performed.Then balloon angioplasty of right popliteal artery and right sfa was performed using 5 mm x 220 mm sterling balloon followed by placement of 5 mm x 150 mm non-boston scientific stent from the p3 segment of right popliteal artery extending back to the p1 segment and 6 mm x 100 mm eluvia stent to the most proximal aspect of the lesion.Subsequently, on the same day, balloon angioplasty of proximal posterior tibial artery and peroneal artery were performed using 4 mm x 100 mm drug eluting balloon.Per edc, on (b)(6) 2022, the event was considered to be resolved.

Manufacturer Narrative

B5 updated in the supplemental report.A1: patient identifier- (b)(6).A2: patient age at time of enrollment- 62 years old.

Event Description

Elegance study.It was reported that an occlusion occurred, requiring additional intervention and device.The subject underwent treatment with the ranger drug coated balloon on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the right distal superficial femoral artery, right proximal popliteal artery, right mid popliteal artery extending into right distal popliteal artery with proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm with lesion length of 150 mm and 100% stenosis and was classified as tasc ii c lesion.Prior to target lesion treatment, balloon dilatation was performed using 3.0 mm x 100 mm coyote pta balloon.The treatment of target lesion was performed by dilatation using study device 6 mm x 200 mm ranger drug coated balloon.Following post treatment stent was placed with 6.0 mm x 130 mm innova bare metal stent and the final residual stenosis was noted to be 5%.On the same day, the subject was discharged on dual antiplatelet therapy.Per edc, on (b)(6) 2022, the subject was noted with the symptoms related to occlusion of distal right sfa and popliteal artery.Per source, on the same day, pvl arterial duplex right lower extremity revealed occlusion through right mid sfa to distal sfa and stented right popliteal artery.On (b)(6) 2022, abi was noted as 0.32 (0.73) and rle arterial duplex revealed occlusion of the right mid to distal sfa.On (b)(6) 2022, 265 days post index procedure, 100% stenosis noted in distal sfa, proximal popliteal artery, mid popliteal artery and distal popliteal artery were treated by percutaneous transluminal angioplasty, drug eluting stent and stent-graft placement.Final residual stenosis was noted to be 5%.Per source, on the same day, ivus evaluation of right tibioperoneal trunk, popliteal artery, superficial femoral artery was performed.Then balloon angioplasty of right popliteal artery and right sfa was performed using 5 mm x 220 mm sterling balloon followed by placement of 5 mm x 150 mm non-boston scientific stent from the p3 segment of right popliteal artery extending back to the p1 segment and 6 mm x 100 mm eluvia stent to the most proximal aspect of the lesion.Subsequently, on the same day, balloon angioplasty of proximal posterior tibial artery and peroneal artery were performed using 4 mm x 100 mm drug eluting balloon.Per edc, on (b)(6) 2022, the event was considered to be resolved.It was further reported that the target lesion was located in the right proximal superficial femoral artery, right distal superficial femoral artery, right proximal popliteal artery, right mid popliteal artery extending into right distal popliteal artery.

• Brand Name: INNOVA
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17248660
• MDR Text Key: 318344434
• Report Number: 2124215-2023-34534
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 07/13/2023
• Supplement Dates FDA Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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