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

Model Number	26924
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent premature deployment occurred.The stenosed target lesion was located in the severely calcified brachial artery and a shockwave device was performed.An 8.0x30x75cm express ld stent balloon expandable was crossed for treatment.However, when the device was pulled back to be repositioned for more precision, the stent slid off of the stent balloon catheter, thus dislodged inside the patient.The device was taken out by snaring through the femoral artery and was fully recovered.There were no fragments left inside the body and the procedure was completed via angioplasty with another device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that stent premature deployment occurred.The stenosed target lesion was located in the severely calcified brachial artery and a shockwave device was performed.An 8.0x30x75cm express ld stent balloon expandable was crossed for treatment.However, when the device was pulled back to be repositioned for more precision, the stent slid off of the stent balloon catheter, thus dislodged inside the patient.The device was taken out by snaring through the femoral artery and was fully recovered.There were no fragments left inside the body and the procedure was completed via angioplasty with another device.There were no patient complications nor injuries reported.It was further reported that the correct complaint device was an 8 x 60 x 130 innova stent.

• 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: 18302811
• Report Number: 2124215-2023-69999
• Device Sequence Number: 20566964
• Product Code: NIP
• UDI-Device Identifier: 08714729874188
• UDI-Public: 08714729874188
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,Followup
• Report Date (Section B): 01/18/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0030241941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 12/25/2023
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown