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 Thrombosis (2100); Thrombosis/Thrombus (4440)

Event Date 07/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that stent thrombosis occurred.The subject was enrolled in the (b)(6) study on (b)(6) 2018 and the index procedure was performed on the same day.The target lesion was located in right distal superficial femoral artery (sfa) with 99% stenosis and was 30 mm long with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm and was classified as tasc ii a lesion.The target lesion was treated with direct placement of a 6 mm x 60 mm study stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2018, the subject was discharged on aspirin.On (b)(6) 2020, stent thrombosis was noted.On (b)(6) 2020, the subject was hospitalized for planned intervention.On (b)(6) 2020, the 100% stenosis in left distal sfa including proximal popliteal artery (ppa) which was 20 mm long with a proximal reference vessel diameter of 6 mm with presence of thrombus was intervened using drug coated balloon.Post procedure, there was 10% residual stenosis.On (b)(6) 2020, event was considered to be resolved/ recovered.

Event Description

It was reported that stent thrombosis occurred.The subject was enrolled in the eminent study on (b)(6) and the index procedure was erformed on the same day.The target lesion was located in right distal superficial femoral artery (sfa) with 99% stenosis and was 30 mm long with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm and was classified as tasc ii a lesion.The target lesion was treated with direct placement of a 6 mm x 60 mm study stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2018, the subject was discharged on aspirin.On 03-jul-2020, stent thrombosis was noted.On (b)(6) 2020, the subject was hospitalized for planned intervention.On (b)(6) 2020, the 100% stenosis in left distal sfa including proximal popliteal artery (ppa) which was 20 mm long with a proximal reference vessel diameter of 6 mm with presence of thrombus was intervened using drug coated balloon.Post procedure, there was 10% residual stenosis.On (b)(6) 2020, event was considered to be resolved/ recovered.It was further reported that on (b)(6) 2020, the subject presented with relapsing claudication symptoms upon walking a short distance (greater than 50m).Doppler ultrasound scan performed on the same day revealed occlusion of the stent in the right sfa.Walking rehabilitation was performed but did not result in any real clinical improvement.No other action was taken at the time of diagnosis.Intervention was planned on a later date as the subject was diagnosed with covid-19.On (b)(6) 2020, angiography revealed insignificant multiple, multi-level stenosis in the mid third and occlusion of the distal third of the right sfa.A 6f non-boston scientific laser aspirating catheter was inserted into the target lesion, and numerous intrastent clots were removed.Repeat angiography showed intrastent multi-level narrow persistent stenosis.Therefore, a whole stent angioplasty using a 6 mm x 80 mm non-drug eluting balloon and a 6mm x 80 mm drug eluting balloon was performed.Post procedural angiography revealed satisfactory results with removal of significant intra stent stenosis with 10% residual stenosis.The subject was recommended to continue rivaroxaban and kardegic 75mg.On (b)(6) 2020, a doppler scan revealed patent and deployed correctly with moderated myointimal hyperplasia and absence of stenosing hemodynamics lesions at the right sfa.On (b)(6) 2020, the subject was discharged home and will be seen for follow-up in 3 to 4 months.

Manufacturer Narrative

A1: patient identifier: (b)(6).E1: initial reporter address: (b)(6) hospital.

• Brand Name: INNOVA
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10858567
• MDR Text Key: 216832909
• Report Number: 2134265-2020-15966
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 26920
• Device Catalogue Number: 26920
• Device Lot Number: 0020466863
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR