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

Model Number	26924
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was difficulty removing the stent delivery system.A 8x60x130 innova self-expanding stent was selected for use in the subclavian artery.The stent was deployed successfully.Upon removal of the stent delivery system, the system was difficult to remove from the non-boston scientific guidewire.A hemostat was applied to the outer blue sheath lining to help with the removal of the device off of the wire.After the stent delivery system was removed, the thumbwheel was visibly loose and fell into the body of the handle.There were no patient complications, and the procedure was successfully completed.
Additional Manufacturer Narrative
Device eval by mfr: the device was returned and analysis was completed.The returned product consisted of an innova self-expanding stent system with a 0.035 hydrophilic guidewire stuck on the inner liner.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, 36cm, and 50cm from the nosecone.The sheath is flattened 14.5cm from the nosecone.The pull rack is bent at the proximal end of the handle.The inner liner and proximal inner are no longer attached to the handle.Microscopic examination revealed no additional damages.The device was disassembled to verify if there were any additional damages inside the handle.It was confirmed that the inner liner separated at the clip.
Event or Problem Description
It was reported there was difficulty removing the stent delivery system.A 8x60x130 innova self-expanding stent was selected for use in the subclavian artery.The stent was deployed successfully.Upon removal of the stent delivery system, the system was difficult to remove from the non-boston scientific guidewire.A hemostat was applied to the outer blue sheath lining to help with the removal of the device off of the wire.After the stent delivery system was removed, the thumbwheel was visibly loose and fell into the body of the handle.There were no patient complications, and the procedure was successfully completed.

• 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: 13559691
• Report Number: 2134265-2022-01189
• Device Sequence Number: 14567093
• Product Code: NIP
• UDI-Device Identifier: 08714729874188
• UDI-Public: 08714729874188
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 03/15/2022

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: 07/11/2026
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0027645575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown