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

Model Number	H74939293086070
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G4 - premarket / 510(k) #: k133110, p090003.
Event or Problem Description
It was reported that stent damage occurred, requiring placement of another stent.The over 70% stenosed target lesion was located in the mildly tortuous and moderately calcified common iliac artery.An 8.0x30x75cm express ld stent was used for treatment.However, after deployment, an angiogram showed that the distal end of the stent was unraveled and appeared to fell apart.As a result, an express ld 8x20x135 was deployed to cover the portion of the previous stent.The catheter was removed with no issues, and the procedure was completed.The patient is expected to fully recover.
Additional Manufacturer Narrative
Additional information report is being filed to update d4 (lot number).
Event or Problem Description
It was reported that stent damage occurred, requiring placement of another stent.The over 70% stenosed target lesion was located in the mildly tortuous and moderately calcified common iliac artery.An 8.0x30x75cm express ld stent was used for treatment.However, after deployment, an angiogram showed that the distal end of the stent was unraveled and appeared to fell apart.As a result, an express ld 8x20x135 was deployed to cover the portion of the previous stent.The catheter was removed with no issues, and the procedure was completed.The patient is expected to fully recover.It was further reported that an innova self-expanding stent was used, and not an express ld 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: 21632499
• Report Number: 2124215-2025-16641
• Device Sequence Number: 13072995
• Product Code: NIP
• UDI-Device Identifier: 08714729873822
• UDI-Public: (01)08714729873822(17)291211(10)35476288
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 04/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939293086070
• Device Catalogue Number: H74939293086070
• Device Lot Number: 0035476288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/24/2025
• Date Device Manufactured: 12/12/2024
• 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