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

Device Problem Fracture (1260)

Patient Problems Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 10/01/2015

Event Type  Injury  

Event Description

It was reported via journal article that 2 stents fractured resulting in in-stent thrombosis and restenosis.The study compared drug-coated balloon (dcb) and bare metal stent (bms) for primary lesions in femoropopliteal artery disease in chinese population and to make subgroup analysis between the groups.Local anesthesia was used in all operations.Arterial access-site selection was left to the discretion of the investigator.After arterial puncture and placement of a 5-7f introducer sheath, an initial dose 01 5000 iu heparin was administered.Intraluminal or subintimal lesion crossing was performed, using standard guide wires and catheters.Pretreatment for target lesions was then performed with balloon angioplasty.According to the diameter of non lesion arteries, balloons with diameters ranging from small to large were used for predilation.Dcb or bms was then used after predilation depending on the decision of chief surgeon.Dcb was kept inflated for at least 180 second and balloon size selection was based on a visual estimate.Two innova stents in the bms group occurred fracture at 2- and 4-months post operation and resulted in in-stent thrombosis and restenosis.Both patients received endovascular thrombectomy and covered stent insertion afterwards.

Manufacturer Narrative

Date of event was approximated based on date of study in the article.Initial reporter address 1: xizhimen south street, west district haocheng ma, xuemin zhang, jing li, quingle li, wei li, yang jiao, jingjun jiang, changshun hem, zhibin he, weihao li, tao zhang, and xiaoming zhang, p.R.China.Mid-term efficacy and safety of drug-coated balloon versus nitinol bare metal stent for primary lesions in femoropopliteal artery disease.Ann vasc surg 2022; 81: 316-323.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15906536
• MDR Text Key: 304718545
• Report Number: 2124215-2022-50030
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention