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

Model Number	26924
Medical Device Problem Codes	Premature Activation (1484); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent inadvertently deployed.A 7 x 40 x 130 innova self-expanding stent was selected for use in a vascular intervention.A contralateral approach was used to access the 99% stenosed target lesion that was severely calcified and located in the moderately tortuous superficial femoral artery.The lesion was pre-dilated with a balloon, but the innova would not cross the lesion.The device was removed.The stent looked defective; it looked like the middle catheter had come back, so the distal tip of the stent was exposed.Another innova stent was used to complete the procedure.No patient complications were reported.
Event or Problem Description
It was reported that the stent inadvertently deployed.A 7 x 40 x 130 innova self-expanding stent was selected for use in a vascular intervention.A contralateral approach was used to access the 99% stenosed target lesion that was severely calcified and located in the moderately tortuous superficial femoral artery.The lesion was pre-dilated with a balloon, but the innova would not cross the lesion.The device was removed.The stent looked defective; it looked like the middle catheter had come back, so the distal tip of the stent was exposed.Another innova stent was used to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device eval 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 a kink to the outer sheath at the nosecone.The stent was partially deployed 1.3cm from the middle sheath.Microscopic examination revealed no additional damages.The pull rack and yellow thumbwheel lock were still in the manufactured position.

• 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: 16048585
• Report Number: 2124215-2022-54561
• Device Sequence Number: 20442312
• Product Code: NIP
• UDI-Device Identifier: 08714729874089
• UDI-Public: 08714729874089
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 02/15/2023

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: 0028918802
• 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: 12/02/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 12/26/2022
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown