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

Model Number	H74939293061530
Medical Device Problem Codes	Fracture (1260); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent partially broke, and the procedure was not completed.Vascular access was obtained via brachial approach.The chronic totally occluded target lesion was located in the moderately tortuous and severely calcified superficial femoral artery (sfa).A 6 x 150 x 130 innova vascular self-expanding stent was advanced over.014 non-boston scientific guidewire through a 6f x 90cm sheath.During the procedure, the roller continued to click, but the deployment stopped, it was only about 20mm of the stent was deployed.It was attempted to manually deploy the stent by pulling the blue grip until past white arrow, but it was unsuccessful.Eventually, while trying to deploy and remove the stent, it partially broke.The other fractured part was still attached in the deployment system when removed along with the 6f x 90cm sheath.The detached portion of the stent remains implanted in the sfa.The procedure was not completed, as the patient still had a blood flow in the sfa, nothing else was done.The patient was under general anesthesia.No complications were reported.
Event or Problem Description
It was reported that the stent partially broke, and the procedure was not completed.Vascular access was obtained via brachial approach.The chronic totally occluded target lesion was located in the moderately tortuous and severely calcified superficial femoral artery (sfa).A 6 x 150 x 130 innova vascular self-expanding stent was advanced over.014 non-boston scientific guidewire through a 6f x 90cm sheath.During the procedure, the roller continued to click, but the deployment stopped, it was only about 20mm of the stent was deployed.It was attempted to manually deploy the stent by pulling the blue grip until past white arrow, but it was unsuccessful.Eventually, while trying to deploy and remove the stent, it partially broke.The other fractured part was still attached in the deployment system when removed along with the 6f x 90cm sheath.The detached portion of the stent remains implanted in the sfa.The procedure was not completed, as the patient still had a blood flow in the sfa, nothing else was done.The patient was under general anesthesia.No complications were reported.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the innova self-expanding stent system was returned for analysis.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the handle is open and missing.There are multiple kinks along the device.The retainer is separated from the pull rack.The pull rack is separated 4.5cm from the distal end.The proximal end of the pull rack is missing.The stent is separated 10.2cm while approximately 3.2cm is deployed.The distal end of the separated stent is missing.Microscopic examination revealed no additional damages.The stent is no longer inside the middle sheath.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis found damage to the device that could have contributed to the reported event.

• 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: 20836398
• Report Number: 2124215-2024-75302
• Device Sequence Number: 21017385
• Product Code: NIP
• UDI-Device Identifier: 08714729874041
• UDI-Public: 08714729874041
• 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,Followup
• Report Date (Section B): 03/26/2025

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: H74939293061530
• Device Catalogue Number: H74939293061530
• Device Lot Number: 0030980833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2023
• 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: Other
• Patient Sex: Unknown