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

Model Number	26929
Medical Device Problem Codes	Premature Activation (1484); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device media analysis: 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 kinks to the outer sheath at the nosecone and 47.5cm from the nosecone.Microscopic examination revealed no additional damages.The thumbwheel lock and pull rack were still in the manufactured position.The middle sheath was no longer sitting on top of the proximal end of the tip.The stent was still inside the middle sheath.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis found kinks on the device which could have contributed to the reported difficulty to advance and remove.
Event or Problem Description
It was reported that there was resistance when advancing the stent through the sheath, and the stent began to deploy prematurely.Additionally, there was resistance upon removal.An innova 7 x 120 x 130 was selected for use.During insertion of the delivery system into the 6f sheath, there was resistance noted.When the delivery system was approximately half-way into the sheath, the stent began to deploy partially.The delivery system and stent were removed with significant resistance noted.The innova was replaced with an epic vascular self-expanding stent, which was able to advance through the same 6f sheath without issue.The procedure was completed and there were no reported adverse consequences to the patient.

• 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: 16294329
• Report Number: 2124215-2023-03665
• Device Sequence Number: 6523004
• Product Code: NIP
• UDI-Device Identifier: 08714729874126
• UDI-Public: 08714729874126
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2023

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: 26929
• Device Catalogue Number: 26929
• Device Lot Number: 0030440800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EPIC VASCULAR SELF-EXPANDING STENT SYSTEM
• Patient Sex: Unknown