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	01/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that inadvertent deployment occurred.A 8 x 60 x 130 innova vascular stent was selected for use.During unpacking, the stent was already exposed.The clip was still on the device.The device could not be prepped as the stent was not in the catheter.The procedure was completed with another innova stent.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: 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 that the stent is partially deployed approximately 15mm from the middle sheath.There is a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The lock and pull rack are still in the manufactured location but the middle sheath is no longer sitting on top of the proximal end of the tip.Inspection of the remainder of the device, revealed no other damage or irregularities.
Event or Problem Description
It was reported that inadvertent deployment occurred.A 8 x 60 x 130 innova vascular stent was selected for use.During unpacking, the stent was already exposed.The clip was still on the device.The device could not be prepped as the stent was not in the catheter.The procedure was completed with another innova stent.There were no patient complications.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16292534
• Report Number: 2124215-2023-04571
• Device Sequence Number: 17742542
• Product Code: NIP
• UDI-Device Identifier: 08714729874188
• UDI-Public: 08714729874188
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

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: 0029100214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown