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

Model Number	H74939293061530
Medical Device Problem Codes	Nonstandard Device (1420); Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent appeared shorter than expected, requiring an additional device.The target lesion was located in the distal superficial femoral artery.A 6 x 150 x 130 innova self-expanding stent was selected for use.During the procedure, the physician observed that the deployed stent length appeared shorter than anticipated but proceeded with deployment.Once fully released within the vessel, the stent continued to present as shorter than expected.This observation was further substantiated when a 5 x 150 charger balloon was advanced to the lesion and found to be significantly longer than the stent in place.It was subsequently suspected that the stent deployed, labeled as a 6 x 150, may have actually been a 6 x 100.The intervention was completed successfully using an alternative device.There were no patient complications associated with this event.
Additional Manufacturer Narrative
Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review performed for the innova device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefits for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established based on the inability to assign a most probable cause for this event from the information provided and the device/packaging not being returned for analysis.
Event or Problem Description
It was reported that the stent appeared shorter than expected, requiring an additional device.The target lesion was located in the distal superficial femoral artery.A 6 x 150 x 130 innova self-expanding stent was selected for use.During the procedure, the physician observed that the deployed stent length appeared shorter than anticipated but proceeded with deployment.Once fully released within the vessel, the stent continued to present as shorter than expected.This observation was further substantiated when a 5 x 150 charger balloon was advanced to the lesion and found to be significantly longer than the stent in place.It was subsequently suspected that the stent deployed, labeled as a 6 x 150, may have actually been a 6 x 100.The intervention was completed successfully using an alternative device.There were no patient complications associated with this event.It was further reported that the target lesion was 56% stenosed, non-tortuous, and mildly calcified.The stent was deployed in the vessel, after which the catheter was removed from the patient intact and disposed of.The physician was satisfied with the stent's placement and was able to treat the intended length by deploying a second stent.Therefore, extraction of the initially deployed stent from the vessel was not required.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review performed for the innova device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefits for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established based on the inability to assign a most probable cause for this event from the information provided and the device/packaging not being returned for analysis.

• 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: 24817808
• Report Number: 2124215-2026-19061
• Device Sequence Number: 21256122
• Product Code: NIP
• UDI-Device Identifier: 08714729874041
• UDI-Public: (01)08714729874041(17)310108(10)38310283
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 04/23/2026

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: H74939293061530
• Device Catalogue Number: H74939293061530
• Device Lot Number: 0038310283
• 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: 03/11/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 04/23/2026
• Date Device Manufactured: 01/09/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON - 5X150 CHARGER.; BALLOON - 5X150 CHARGER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown