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	12/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that inadvertent deployment occurred.An 8 x 60 x 130 innova vascular stent was selected for use in a superficial femoral artery stenting.The device was opened on a sterile field.However, during preparation, it was noted that the distal tip of the stent had flared out.The yellow safety clamp was still on the device and the thumb roller was not touched.The plunger of device was not pulled out either.The device was immediately removed from sterile field and another of same device was opened and deployed successfully.No patient complications were reported.
Event or Problem Description
It was reported that inadvertent deployment occurred.An 8 x 60 x 130 innova vascular stent was selected for use in a superficial femoral artery stenting.The device was opened on a sterile field.However, during preparation, it was noted that the distal tip of the stent had flared out.The yellow safety clamp was still on the device and the thumb roller was not touched.The plunger of device was not pulled out either.The device was immediately removed from sterile field and another of same device was opened and deployed successfully.No patient complications were reported.
Additional Manufacturer Narrative
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 is partially deployed 12mm from the distal end of the middle sheath.Microscopic examination revealed no additional damages.The pull rack and yellow thumbwheel lock is still in the manufactured position.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis found damage that could have contributed to the inadvertent deployment.

• Brand Name: INNOVA VASCULAR
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18440066
• Report Number: 2124215-2023-70984
• Device Sequence Number: 6931252
• Product Code: NIP
• UDI-Device Identifier: 08714729874188
• UDI-Public: 08714729874188
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 01/22/2024

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: 0030241941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown