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

Model Number	26929
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the stent foreshortened.A 7mm x 120mm x 130cm innova was selected for use in a right leg angiogram with intervention and popliteal access.The 70-80% stenosed target lesion in the superficial femoral artery (sfa) was not calcified, and the anatomy was not tortuous.The lesion was pre-dilated.During the procedure, the stent was approximately 20% deployed in the distal sfa when the stent was noted to have foreshortened.The stent was fully deployed without resistance and post-dilated.The innova foreshortened from its stated 120mm length to approximately 100mm in length.The procedure was completed.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: 11165081
• Report Number: 2134265-2021-00256
• Device Sequence Number: 897286
• Product Code: NIP
• UDI-Device Identifier: 08714729874126
• UDI-Public: 08714729874126
• 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
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2021

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: 11/01/2025
• Device Model Number: 26929
• Device Catalogue Number: 26929
• Device Lot Number: 0026289536
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 01/13/2021
• Patient Sequence Number: 1