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 Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 10/17/2022

Event Type  Injury  

Event Description

Eminent clinical trial.It was reported that in-stent restenosis occurred.The subject was enrolled in the eminent study on (b)(6) 2018 and the index procedure was performed on the same day.Target lesion was located in right mid superficial femoral artery (sfa) with 100% stenosis and was 160 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 c lesion.Target lesion was treated with pre-dilatation, followed by placement of 6 mm x 150 mm and 6 mm x 120 mm study stents.Post dilatation was performed with final stenosis of 20%.On (b)(6) 2018, the subject was discharged with antiplatelet therapy.On (b)(6) 2022, 1506 days post index procedure, the subject presented to the clinic with unknown symptoms.On the same day, the subject was hospitalized for further evaluation and treatment.X ray of target limb was performed, revealed stenosis in the target limb.Based on the diagnostic findings, the subject was diagnosed with tight stenosis in the right superficial femoral artery (sfa).Interventional procedure was recommended to treat the event.On (b)(6) 2022, 1506 days post index procedure, 50% stenosis in the target lesion (right proximal to mid) with 6 mm reference vessel diameter and 40 mm lesion length was treated by performing percutaneous transluminal angioplasty, followed by implantation of a stent.Post procedure resulted in 50% of residual stenosis and no thrombus was seen.

Manufacturer Narrative

Age at time of event: 65 years old at the time of study enrollment.

Event Description

Eminent clinical trial.It was reported that in-stent restenosis occurred.The subject was enrolled in the eminent study on 11-sep-2018 and the index procedure was performed on the same day.Target lesion was located in right mid superficial femoral artery (sfa) with 100% stenosis and was 160 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 c lesion.Target lesion was treated with pre-dilatation, followed by placement of 6 mm x 150 mm and 6 mm x 120 mm study stents.Post dilatation was performed with final stenosis of 20%.On (b)(6) 2018 the subject was discharged with antiplatelet therapy.On (b)(6) 2022 1506 days post index procedure, the subject presented to the clinic with unknown symptoms.On the same day, the subject was hospitalized for further evaluation and treatment.X ray of target limb was performed, revealed stenosis in the target limb.Based on the diagnostic findings, the subject was diagnosed with tight stenosis in the right superficial femoral artery (sfa).Interventional procedure was recommended to treat the event.On (b)(6) 2022 1506 days post index procedure, 50% stenosis in the target lesion (right proximal to mid) with 6 mm reference vessel diameter and 40 mm lesion length was treated by performing percutaneous transluminal angioplasty, followed by implantation of a stent.Post procedure resulted in 0% residual stenosis and no thrombus was seen.It was further reported that the subject presented for 48-month protocol scheduled follow-up visit on (b)(6) 2022.On (b)(6) 2022 1497 days post index procedure, the subject presented with recurrence of intermittent claudication in right sfa and walking distance of less than 1km.Doppler ultrasound performed on right limb revealed proximal stenosis of the stent at 1.5 m/s associated with intrastent stenosis.Ankle brachial index was 0.9 on right.On (b)(6) 2022 the subject was hospitalized for a planned interventional procedure.On (b)(6) 2022 , the subject was discharged home with resumption of usual treatment with addition of plavix for a duration of three months and suggested to perform doppler ultrasound of the lower limbs in one month.On (b)(6) 2022 the subject re-visited for a follow up checkup, and the arterial doppler ultrasound examination performed on the same day to lower limbs revealed, good morphological, hemodynamic result of angioplasty and stenting of the right sfa, extending by a single patent arterial pathway in the lower leg with continuous correct flow to the posterior tibial artery.On (b)(6) 2022 as a part of follow up checkup, subject reported that the walking distance was unlimited.The doppler ultrasound performed showed good result for the dilatation of the right sfa.

Manufacturer Narrative

Corrections: b3 date of event corrected.B5 describe event or problem included corrections to event date and residual stenosis post intervention on 26-oct-2022.A2: age at time of event: 65 years old at the time of study enrollment.

Manufacturer Narrative

Age at time of event: 65 years old at the time of study enrollment.

Event Description

Eminent clinical trial.It was reported that in-stent restenosis occurred.The subject was enrolled in the eminent study on (b)(6) 2018 and the index procedure was performed on the same day.Target lesion was located in right mid superficial femoral artery (sfa) with 100% stenosis and was 160 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 c lesion.Target lesion was treated with pre-dilatation, followed by placement of 6 mm x 150 mm and 6 mm x 120 mm study stents.Post dilatation was performed with final stenosis of 20%.On (b)(6) 2018, the subject was discharged with antiplatelet therapy.On (b)(6) 2022, 1506 days post index procedure, the subject presented to the clinic with unknown symptoms.On the same day, the subject was hospitalized for further evaluation and treatment.X ray of target limb was performed, revealed stenosis in the target limb.Based on the diagnostic findings, the subject was diagnosed with tight stenosis in the right superficial femoral artery (sfa).Interventional procedure was recommended to treat the event.On (b)(6) 2022, 1506 days post index procedure, 50% stenosis in the target lesion (right proximal to mid) with 6 mm reference vessel diameter and 40 mm lesion length was treated by performing percutaneous transluminal angioplasty, followed by implantation of a stent.Post procedure resulted in 50% of residual stenosis and no thrombus was seen.It was further reported that the subject presented for 48-month protocol scheduled follow-up visit on (b)(6) 2022.On (b)(6) 2022, 1499 days post index procedure, the subject presented with recurrence of intermittent claudication in right sfa and walking distance of less than 1km.Doppler ultrasound performed on right limb revealed proximal stenosis of the stent at 1.5 m/s associated with intrastent stenosis.Ankle brachial index was 0.9 on right.On (b)(6) 2022, the subject was hospitalized for a planned interventional procedure.On (b)(6) 2022, the subject was discharged home with resumption of usual treatment with addition of plavix for a duration of three months and suggested to perform doppler ultrasound of the lower limbs in one month.On (b)(6)2022, the subject re-visited for a follow up checkup, and the arterial doppler ultrasound examination performed on the same day to lower limbs revealed, good morphological, hemodynamic result of angioplasty and stenting of the right sfa, extending by a single patent arterial pathway in the lower leg with continuous correct flow to the posterior tibial artery.On (b)(6) 2022, as a part of follow up checkup, subject reported that the walking distance was unlimited.The doppler ultrasound performed showed good result for the dilatation of the right sfa.

• 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: 16022125
• MDR Text Key: 305880397
• Report Number: 2124215-2022-53292
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 26920
• Device Catalogue Number: 26920
• Device Lot Number: 0020482537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male