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

Model Number	H74939293076030
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred, requiring surgical intervention for removal.A 7 x 60 x 130 innova? vascular stent was to treat chronic limb ischemia (cli).During the procedure, the physician used two access sites to the target location.A 6f non-boston scientific sheath was advanced over a.035 glidewire advantage to deploy the innova stent.During deployment, the tip of the stent fractured.The physician attempted to remove the detached stent tip through access in the tibial or pedal artery with a 5fr sheath.A ranger balloon was advanced; however, it became kinked.Surgical intervention was performed to access the detached stent.The stent was partially explanted, and a portion remains implanted.The procedure was then completed using an alternate method.There were no complications resulting from this event, and the patient is expected to fully recover.
Additional Manufacturer Narrative
Corrected h6 (device codes).Device evaluated by mfr: only a section of inner sheath and tip of the device was returned to our post market quality assurance laboratory.The inner has separated from the delivery system at approximately 25mm proximal of the tip of the device.No damage or issues were noted with the tip of the device.This concludes the product analysis.
Event or Problem Description
It was reported that tip detachment occurred, requiring surgical intervention for removal.A 7 x 60 x 130 innova? vascular stent was to treat chronic limb ischemia (cli).During the procedure, the physician used two access sites to the target location.A 6f non-boston scientific sheath was advanced over a.035 glidewire advantage to deploy the innova stent.During deployment, the tip of the stent fractured.The physician attempted to remove the detached stent tip through access in the tibial or pedal artery with a 5fr sheath.A ranger balloon was advanced; however, it became kinked.Surgical intervention was performed to access the detached stent.The stent was partially explanted, and a portion remains implanted.The procedure was then completed using an alternate method.There were no complications resulting from this event, and the patient is expected to fully recover.
Additional Manufacturer Narrative
Corrected h6.Device codes, patient codes.This report was amended to update international medical device regulators forum (imdrf) codes.Incomplete coding of this event was identified during a retrospective review of complaints associated with capa-8580, which focused on identifying and remediating incomplete coding of events.Device analysis results: a section of the inner sheath and tip of the device was returned to our post market quality assurance laboratory.The inner sheath was separated from the delivery system at approximately 25mm proximal of the tip of the device.No damage or issues were noted with the tip of the device.Device history review: it was confirmed that this device met manufacturing specification prior to distribution and there are no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation is assigned a conclusion code of adverse event related to procedure.This is based on the probability of the shaft becoming severely kinked during deployment of the stent, causing a weak point which then separated as the user attempted to withdraw the delivery system from the patient.
Event or Problem Description
It was reported that tip detachment occurred, requiring surgical intervention for removal.A 7 x 60 x 130 innova? vascular stent was to treat chronic limb ischemia (cli).During the procedure, the physician used two access sites to the target location.A 6f non-boston scientific sheath was advanced over a.035 glidewire advantage to deploy the innova stent.During deployment, the tip of the stent fractured.The physician attempted to remove the detached stent tip through access in the tibial or pedal artery with a 5fr sheath.A ranger balloon was advanced; however, it became kinked.Surgical intervention was performed to access the detached stent.The stent was partially explanted, and a portion remains implanted.The procedure was then completed using an alternate method.There were no complications resulting from this event, and the patient is expected to fully recover.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21901300
• Report Number: 2124215-2025-24966
• Device Sequence Number: 8713470
• Product Code: NIP
• UDI-Device Identifier: 08714729874096
• UDI-Public: (01)08714729874096(17)300123(10)35701704
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2026

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: H74939293076030
• Device Catalogue Number: H74939293076030
• Device Lot Number: 0035701704
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 03/30/2026
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 06/05/2025; 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• 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 Age: 73 YR
• Patient Sex: Female