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

Model Number	26929
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent inadvertent deployment occurred.The patient was being treated for iliac stenosis.An 8 x 120 x 130 innova vascular was opened, flushed, and removed from tray.The stent was being placed on the wire when it was noticed that the end of the stent was flared.The clip was still attached to the deployment wheel and had not been moved.The device was removed from the wire and was deployed on the table.The procedure was completed using an alternate method.No patient complications were reported.
Event or Problem Description
It was reported that stent inadvertent deployment occurred.The patient was being treated for iliac stenosis.An 8 x 120 x 130 innova vascular was opened, flushed, and removed from tray.The stent was being placed on the wire when it was noticed that the end of the stent was flared.The clip was still attached to the deployment wheel and had not been moved.The device was removed from the wire and was deployed on the table.The procedure was completed using an alternate method.No patient complications were reported.
Additional Manufacturer Narrative
The device was returned for evaluation.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the stent is deployed and no longer inside the sheath.There is a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The lock and pull rack are no longer in the manufactured location.Inspection of the remainder of the device, revealed no other damage or irregularities.No other issues were identified during the product analysis.

• 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: 19177718
• Report Number: 2124215-2024-21802
• Device Sequence Number: 15304444
• Product Code: NIP
• UDI-Device Identifier: 08714729874218
• UDI-Public: 08714729874218
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/14/2024

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: 26929
• Device Catalogue Number: 26929
• Device Lot Number: 0031393468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2023
• 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 Age: 39 YR
• Patient Sex: Male
• Patient Race: White