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

Model Number 26920

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

Patient Problems Pain (1994); Arteriosclerosis/ Atherosclerosis (4437); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 10/17/2022

Event Type  Injury  

Event Description

Eminent clinical study.It was reported that in-stent restenosis and thrombosis occurred.The subject was enrolled in the eminent study on (b)(6) 2019 and the index procedure was performed on the same day.Target lesion was located in right distal superficial femoral artery (sfa) involving proximal popliteal artery (ppa) with 100% stenosis and was 80 mm long with a proximal reference vessel diameter of 4 mm and distal reference vessel diameter of 4 mm and was classified as tasc ii b lesion.Target lesion was treated with pre-dilatation followed by placement of a 6 mm x 100 mm study stent.Following, post dilation, final stenosis was 0%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2022, 1354 days post index procedure, the subject presented due to pain in the region calf and foot on the right.The symptoms occurred today over the course of the day while walking in the woods and also complained intermittent pain at rest with a warm right foot.On general examination, no open skin lesions in the region of the right lower extremity and the right forefoot more cooler than the left one with slightly reduced general condition due to pain.Pulse status examination on the same day revealed right femoral artery , popliteal artery , posterior tibial artery and -dorsal artery of the foot.On (b)(6) 2022, the ultrasound examination of the right lower extremity performed revealed good flow outcomes across the sfa through to the stent, which has a strong flow in the popliteal artery, distal of the stent there is still a monophasic but considerably weakened flow.Therefore, there is a strong suspicion of in-stent restenosis, most likely caused by thrombosis.On the same day, the subject was hospitalized for further evaluation and treatment.Event was treated medically, and also the subject was recommended to undergo interventional procedure as a treatment.On (b)(6) 2022, digital subtraction angiography (dsa) confirmed the stent occlusion in the proximal popliteal artery.Based on the symptoms and diagnostic findings, the subject was diagnosed with atherosclerosis of the extremity arteries due to pain at rest and thrombotic occlusion of sfa and ppa stent.On (b)(6) 2022, 1355 days post index procedure, 100% stenosis in right distal sfa involving the ppa with 120 mm long lesion length and a reference vessel diameter of 5 mm, was treated with thrombendarteriectomy with ring stripper.Post procedure, dsa performed showed multiple stenosis over the course of the sfa and the popliteal artery.100 % stenosis in the distal sfa involving the ppa was again treated with percutaneous transluminal angioplasty (pta) performed in stages of the entire sfa and pa with a 5 mm x 120 mm balloon.Post procedure resulted in 0% residual stenosis and post angiography showed no further evidence of stenosis and no thrombus was seen.On (b)(6) 2022, the event was considered to be recovered/resolved.On (b)(6) 2022, abi performed revealed 0.99 at right.On (b)(6) 2022, the event was considered as recovered/ resolved and discharged on the same day with the advice xarelto and clopidogrel for 3 months and asa 100 mg was advised for lifelong.

Manufacturer Narrative

Age at time of event: 64 years old at the time of study enrollment.

• Brand Name: INNOVA
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16147536
• MDR Text Key: 307196626
• Report Number: 2124215-2023-01047
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2021
• Device Model Number: 26920
• Device Catalogue Number: 26920
• Device Lot Number: 0022759071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Race: White