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); Discomfort (2330); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 03/23/2022

Event Type  Injury  

Event Description

\eminent clinical study.It was reported that the subject had in-stent thrombosis and vessel occlusion of the superficial femoral artery.The subject was enrolled in the eminent study on (b)(6) 2018 and the index procedure was performed on the same day.The 90% stenosed target lesion was located in the right distal superficial femoral artery (sfa) involving the proximal popliteal artery (ppa) and was 60mm long with a proximal reference vessel diameter of 6mm and distal reference vessel diameter of 6mm and was classified as transatlantic intersociety consensus (tasc) ii b lesion.Pre-dilation was performed followed by placement of the 6x60 study stent.During the procedure a dissection occurred in the distal sfa, for which an additional 6x80 stent was placed.Following post-dilation, the residual stenosis was 5%.The subject was discharged with antiplatelet therapy.On (b)(6) 2022, 1290 days, the subject presented with unknown symptoms and was diagnosed with in-stent thrombosis in the right sfa.The subject was recommended to undergo an interventional procedure as a treatment at a later date.On (b)(6) 2023, the subject was hospitalized for the planned interventional procedure and was treated with medication.The 100% stenosed right mid to distal sfa involving the proximal popliteal artery target lesion with 130mm long and a reference vessel diameter of 6mm was treated with percutaneous transluminal angioplasty using a drug coated balloon.Post procedure, the residual stenosis was 25% and no thrombus was observed.The event was considered resolved.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Eminent clinical study.It was reported that the subject had in-stent thrombosis and vessel occlusion of the superficial femoral artery.The subject was enrolled in the eminent study on (b)(6) 2018 and the index procedure was performed on the same day.The 90% stenosed target lesion was located in the right distal superficial femoral artery (sfa) involving the proximal popliteal artery (ppa) and was 60mm long with a proximal reference vessel diameter of 6mm and distal reference vessel diameter of 6mm and was classified as transatlantic intersociety consensus (tasc) ii b lesion.Pre-dilation was performed followed by placement of the 6x60 study stent.During the procedure a dissection occurred in the distal sfa, for which an additional 6x80 stent was placed.Following post-dilation, the residual stenosis was 5%.The subject was discharged with antiplatelet therapy.On (b)(6) 2022, 1290 days, the subject presented with unknown symptoms and was diagnosed with in-stent thrombosis in the right sfa.The subject was recommended to undergo an interventional procedure as a treatment at a later date.On (b)(6) 2023, the subject was hospitalized for the planned interventional procedure and was treated with medication.The 100% stenosed right mid to distal sfa involving the proximal popliteal artery target lesion with 130mm long and a reference vessel diameter of 6mm was treated with percutaneous transluminal angioplasty using a drug coated balloon.Post procedure, the residual stenosis was 25% and no thrombus was observed.The event was considered resolved.It was further reported that on (b)(6) 2022, the subject presented with continued symptoms of calf claudication when walking slowly and climbing stairs; and leg pain upon getting up in the morning.On the same day, duplex ultrasound was performed on the right limb which revealed flow velocities in the sfa and popliteal arteries of 160 cm/s and 30 cm/s respectively, with mild stenosis in the stent.On arrival, the ankle brachial index (abi) was 0.8 on the right, and 0.9 on the left.Examination showed a good outcome with mild restenosis; therefore, medication was given, and the subject would follow up at a later date.On (b)(6) 2022, the subject presented for follow up with no improvements in symptoms and no changes were noted via duplex ultrasound; however, restenosis was suspected in the right limb.The abi was 0.7 on the right, and 0.9 on the left.The subject was advised to continue the conservative treatment and to follow up at a later date.On (b)(6) 2023, the subject presented for early follow up with symptoms of caudal claudication and frequent nocturnal cramps.Duplex ultrasound revealed discontinued flow in the distal sfa due to occlusion of the right distal sfa in the stent and reperfusion of the right proximal popliteal artery but was noted to be weak.The subject was diagnosed with significant progression of peripheral arterial occlusive disease (paod) in the right sfa stent; therefore, pelvic angiography was recommended.On (b)(6) 2023, as previously noted the subject was hospitalized for the planned interventional procedure.On the same day, arteriography of the pelvic vessels revealed re-occlusion of the right sfa.During the angioplasty, three drug coated balloons were used for the treatment.

• 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: 17299219
• MDR Text Key: 318833878
• Report Number: 2124215-2023-32586
• 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: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2021
• Device Model Number: 26920
• Device Catalogue Number: 26920
• Device Lot Number: 0022156198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Race: White