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

Model Number	26924
Medical Device Problem Codes	Difficult to Insert (1316); Premature Activation (1484); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent inadvertently deployed.A 7 x 40 x 130 innova vascular self-expanding stent was selected for use.After a non-boston scientific balloon ruptured and a possible fragment broke off, it was decided to pin the fragment with a stent in the superficial femoral artery.Upon insertion into the 7fr sheath, there was resistance.The stent could not be advanced in the sheath and was removed.Upon removal, the physician was checking the tip to see if there was an issue with the deployment system and partially deployed the stent in doing so.Upon removing the stent off the guidewire, the deployment system was pulled, completely deploying the stent.After further investigation, the non-boston scientific balloon was found lodged in the sheath.The procedure was completed without a stent.While it was originally planned to jail a piece of the balloon that broke off just outside the sheath, the stent was not needed since the balloon and balloon shaft was found jammed inside the sheath.The sheath and balloon were removed.No patient complications were reported.
Event or Problem Description
It was reported that the stent inadvertently deployed.A 7 x 40 x 130 innova vascular self-expanding stent was selected for use.After a non-boston scientific balloon ruptured and a possible fragment broke off, it was decided to pin the fragment with a stent in the superficial femoral artery.Upon insertion into the 7fr sheath, there was resistance.The stent could not be advanced in the sheath and was removed.Upon removal, the physician was checking the tip to see if there was an issue with the deployment system and partially deployed the stent in doing so.Upon removing the stent off the guidewire, the deployment system was pulled, completely deploying the stent.After further investigation, the non-boston scientific balloon was found lodged in the sheath.The procedure was completed without a stent.While it was originally planned to jail a piece of the balloon that broke off just outside the sheath, the stent was not needed since the balloon and balloon shaft was found jammed inside the sheath.The sheath and balloon were removed.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of an innova vascular 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 no longer inside the device.Microscopic examination revealed no additional damages.The lock was missing while the pull rack and middle sheath were no longer in the manufactured position.Device to device interaction test was performed by inserting the device through a test sheath.The device was able to pass through without any issues.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16485798
• Report Number: 2124215-2023-09824
• Device Sequence Number: 17832225
• Product Code: NIP
• UDI-Device Identifier: 08714729874089
• UDI-Public: 08714729874089
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/03/2023

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: 0030301834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown