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

Model Number	26928
Medical Device Problem Codes	Premature Activation (1484); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: patient around (b)(6).Device evaluated by manufacturer.Returned product consisted of an innova self-expanding stent system with a 6f terumo sheath.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the stent is stuck partially inside the sheath.The stent was stretched/deformed.There was a kink to the outer sheath at the nosecone.There were multiple buckles to the outer sheath.The distal end of the middle sheath was damaged.Microscopic examination revealed damage to the tip.Inspection of the remainder of the device, revealed no other damage or irregularities.
Event or Problem Description
It was reported that the stent prematurely deployed.A 7x100x130 innova self-expanding stent was selected for a procedure in the left superficial femoral artery (sfa).The physician tried to advance the stent through the sheath in a pedal approach to the sfa.When attempted to push through the anatomy, it would not advance.The stent was pulled back and the stent deployed in the sheath.The sheath and stent were both removed from the patient successfully.The procedure was completed using a new sheath and a balloon.No patient complications were reported.

• Brand Name: INNOVA VASCULAR
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9948364
• Report Number: 2134265-2020-04919
• Device Sequence Number: 3296543
• Product Code: NIP
• UDI-Device Identifier: 08714729874119
• UDI-Public: 08714729874119
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2020

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: 08/07/2022
• Device Model Number: 26928
• Device Catalogue Number: 26928
• Device Lot Number: 0024233132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 04/10/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6F TERUMO SLENDER SHEATH