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	06/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that inadvertent deployment occurred.A 7 x 40 x 130 innova was selected for use.During unpacking, the stent was sticking out of the catheter.The procedure was completed with another of the same device.There were no patient complications.
Additional Manufacturer Narrative
Date of event: no date provided, used the first date in the month of the aware date.
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 the thumbwheel lock had been removed and the pull grip was extended 2.0 cm from the manufactured position.The flushing luer was not attached nor returned.Microscopic examination revealed the inner liner had a kink 3.8 cm from the tip.A kink was visible at the nosecone.The stent was deployed and returned.
Event or Problem Description
It was reported that inadvertent deployment occurred.A 7 x 40 x 130 innova was selected for use.During unpacking, the stent was sticking out of the catheter.The procedure was completed with another of the same device.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: 14840804
• Report Number: 2134265-2022-07332
• Device Sequence Number: 11354676
• Product Code: NIP
• UDI-Device Identifier: 08714729874089
• UDI-Public: 08714729874089
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 08/23/2022

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: 04/12/2026
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0027129245
• 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: 06/06/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown