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

Model Number	26928
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent partially deployed and then fractured upon removal.This 6 x 100 x 130 innova vascular stent was selected for use in a percutaneous transluminal angioplasty procedure.The 90% stenosed, moderately tortuous, moderately calcified target lesion was located in the superficial femoral artery.The stent was difficult to advance to the lesion.Once at the lesion, the stent would not deploy as the physician rolled the delivery thumb wheel.Then the thumb wheel stopped rolling completely and the physician then tried to pull the deployment handle; however, the stent did not deploy.The physician then attempted to remove the device, but a small portion of the stent was outside the delivery system, and it caught on the sheath while trying to remove the device from the patient.The stent had elongated and had broken into three pieces.The pieces of stent and the delivery system were pulled out with the wire still in the shaft, and the procedure was completed with a different device.There were no patient complications.The device was disposed of at the healthcare facility; therefore, not available for return.

• Brand Name: INNOVA VASCULAR
• Common Device Name: 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: 17991261
• Report Number: 2124215-2023-58214
• Device Sequence Number: 18188987
• Product Code: NIP
• UDI-Device Identifier: 08714729874027
• UDI-Public: 08714729874027
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26928
• Device Catalogue Number: 26928
• Device Lot Number: 0031636839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown