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

Model Number 26920

Device Problems Fracture (1260); Migration (4003)

Patient Problems Pain (1994); Thrombosis/Thrombus (4440)

Event Date 08/01/2022

Event Type  Injury  

Event Description

It was reported that the patient felt pain and a device fracture was observed.On (b)(6) a 7x80x75 innova self expanding stent was implanted into the patient's axillary vein.Following the procedure, the patient felt pain at the implant site and went to the hospital on (b)(6) an examination found the implanted stent was fractured.The patient was treated through additional procedures.Further information has been requested but has not been provided at this time.

Event Description

It was reported that the patient felt pain and a device fracture was observed.On may 21st, an 7x80x75 innova self expanding stent was implanted into the patient's axillary vein.Following the procedure, the patient felt pain at the implant site and went to the hospital on august 2nd.As a result of the examination, the implanted stent was fractured and the patient was treated through additional procedures.Further information has been requested but has not been provided at this time.It was further reported that the patient first started feeling pain at the implant site on august 1st and was admitted to the hospital on august 2nd.The fractured stent had migrated, and a blood clot formed between the blood vessel and the stent.An additional percutaneous transluminal angioplasty procedure was performed; however, after that, a blood clot occurred again and another non-boston scientific 8mm stent was implanted.Additional stenting was successfully completed despite the stenotic region in the mildly tortuous 6x70 vessel.Clopidogrel and aspirin were given post stenting.

• 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
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15473248
• MDR Text Key: 300556426
• Report Number: 2124215-2022-37418
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26920
• Device Catalogue Number: 26920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• 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
• Patient Age: 52 YR
• Patient Sex: Male