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	04/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that inadvertent deployment occurred.A 5mmx 80mm x 130cm innova vascular stent was selected for a superficial femoral artery intervention procedure.Upon removing the innova vascular stent from the packing hoop, it was observed that the stent was deployed outside of the deployment shaft.The device was replaced with another of the same device to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
Device analysis by manufacturer: returned product consisted of an innova self-expanding stent system.The outer sheath, tip, inner sheath, and the remainder of the device were checked for damage.Visual examination revealed the thumbwheel lock in place and the pull handle in place.The flushing luer was not attached or returned.Microscopic examination revealed the stent had deployed 2.3 cm from the outer sheath.A kink was seen 5 mm from the nosecone.
Event or Problem Description
It was reported that inadvertent deployment occurred.A 5mmx 80mm x 130cm innova vascular stent was selected for a superficial femoral artery intervention procedure.Upon removing the innova vascular stent from the packing hoop, it was observed that the stent was deployed outside of the deployment shaft.The device was replaced with another of the same device to complete the procedure.There were no patient complications reported.

• Brand Name: INNOVA VASCULAR
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14310787
• Report Number: 2134265-2022-05087
• Device Sequence Number: 20162057
• Product Code: NIP
• UDI-Device Identifier: 08714729873921
• UDI-Public: 08714729873921
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/04/2022

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 Expiration Date: 03/09/2026
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0026944570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 06/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male