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

Model Number	26924
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Activation Failure (3270)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent failed to expand, requiring additional intervention.The patient presented for a right lower extremity arteriogram.An 8x40x75 innova self-expanding stent was selected for use in the popliteal artery.Posterior tibial access was obtained for retrograde treatment.During deployment, the stent was hung up on the deployment device.The physician successfully attempted to push the stent off with a balloon.However, the stent did not expand, even when detached from the deployment shaft.The deployment device was removed and damage to the posterior tibial artery was noted.Anterior tibial and peroneal arteries remained intact.A snare was used to attempt to remove the stent.But due to the associated risks, the physician then decided to affix and oppose the stent against the vessel wall with a new innova stent.There were no further patient complications 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: 10574941
• Report Number: 2134265-2020-13160
• Device Sequence Number: 14289026
• Product Code: NIP
• UDI-Device Identifier: 08714729873815
• UDI-Public: 08714729873815
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 09/23/2020

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: 06/29/2025
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0025654187
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR