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 Problem Vascular Dissection (3160)

Event Date 09/10/2018

Event Type  Injury  

Event Description

Eminent clinical study: it was reported that the subject experienced a dissection, requiring an additional stent.Baseline rutherford classification was performed on the subject which revealed category 2 moderate claudication.Baseline angiography analysis of the right distal superficial femoral artery (sfa) involving the proximal popliteal artery (ppa) revealed no calcification, with absence of thrombus, ulceration, or aneurysm.Inflow tract patency (stenosis less than 50%) was observed.The subject therefore underwent treatment with these 6x80x130 and 6x60x130 innova stents as part of the eminent clinical trial.The 90% stenosed target lesion was located in the right distal sfa involving the 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.During the procedure, pre-dilation of the target lesion was performed followed by placement of the 6mm x 60mm study stent.A subsequent dissection occurred in the distal sfa post stent placement.Therefore, an additional 6mm x 80mm study stent was placed.Following post-dilation, the residual stenosis was 5%.The subject was discharged with antiplatelet therapy.

• 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: 17238795
• MDR Text Key: 318210091
• Report Number: 2124215-2023-33762
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2023

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
• Device Expiration Date: 07/29/2021
• Device Model Number: 26920
• Device Catalogue Number: 26920
• Device Lot Number: 0022442263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White