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

Model Number	26924
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event: used 08/01/2024 as the event date was not reported.
Event or Problem Description
It was reported that stent inadvertent deployment occurred.A 7 x 80 x 130 innova stent was selected for the superficial femoral artery (sfa) intervention.However, it was noted that the stent system was intact when it was unpacked, but few struts were visible on the stent.The device was not used for this procedure.No patient complications were reported.
Additional Manufacturer Narrative
B3 - date of event: used 08/01/2024 as the event date was not reported.Device evaluated by mfr: this innova self-expanding stent system was returned.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.A visual examination revealed that the stent is partially deployed approximately 5mm from the middle sheath.There is a kink to the outer sheath at the nosecone and 4cm from the nosecone.A microscopic examination revealed no additional damages.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis found damage that could have contributed to the inadvertent deployment.
Event or Problem Description
It was reported that stent inadvertent deployment occurred.A 7 x 80 x 130 innova stent was selected for the superficial femoral artery (sfa) intervention.However, it was noted that the stent system was intact when it was unpacked, but few struts were visible on the stent.The device was not used for this procedure.No patient complications were reported.

• 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: 20124951
• Report Number: 2124215-2024-53420
• Device Sequence Number: 3101539
• Product Code: NIP
• UDI-Device Identifier: 08714729874102
• UDI-Public: 08714729874102
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0028947284
• 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: 08/07/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2022
• 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
• Patient Sex: Unknown