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

Model Number	26929
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a partial deploy occurred and the stent foreshortened.A 7 x 120 x 30 self-expanding innova stent was selected for use in a procedure in a stenosed superficial femoral artery (sfa).During the procedure, it was reported that the stent did not deploy properly as the stent foreshortened and only deployed 80mm of the 120mm.There were no patient complications reported.A non-bsc stent was used to complete the remaining length of stent needed.
Event or Problem Description
It was reported that a partial deploy occurred and the stent foreshortened.A 7x120x30 self-expanding innova stent was selected for use in a procedure in a stenosed superficial femoral artery (sfa).During the procedure, it was reported that the stent did not deploy properly as the stent foreshortened and only deployed 80mm of the 120mm.There were no patient complications reported.A non-bsc stent was used to complete the remaining length of stent needed.It was further reported that the case was an antegrade approach of the sfa.The physician may have unknowingly restricted the portion of the device near the hub of the sheath which potentially caused the stent to eject from the end of the delivery system and not deploy correctly thus only deploying 80mm of the 120mm.The entirety of the stent was deployed using the thumb wheel.

• 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: 10501898
• Report Number: 2134265-2020-11898
• Device Sequence Number: 2757358
• Product Code: NIP
• UDI-Device Identifier: 08714729874126
• UDI-Public: 08714729874126
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/04/2021
• Device Model Number: 26929
• Device Catalogue Number: 26929
• Device Lot Number: 0022605817
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 09/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention