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

Model Number	26928
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent foreshortened.A 6mm x 100mm x 130cm innova self expanding stent was selected for use to treat a lesion in the lower right leg.The innova stent was correctly deployed; however, the stent foreshortened from it's stated length.The procedure as completed without any patient complications.
Additional Manufacturer Narrative
H6.Evaluation method codes and evaluation conclusion codes were updated.
Event or Problem Description
It was reported that the stent foreshortened.A 6mm x 100mm x 130cm innova self expanding stent was selected for use to treat a lesion in the lower right leg.The innova stent was correctly deployed; however, the stent foreshortened from it's stated length.The procedure was completed without any patient complications.It was further reported that the target lesion was not tortuous, not calcified, and was 70% stenosed.The lesion was predilated and post dilated, and was noted as sized correctly.There was no harm to the patient.The stent remains implanted.

• 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: 11301822
• Report Number: 2134265-2021-01408
• Device Sequence Number: 17402416
• Product Code: NIP
• UDI-Device Identifier: 08714729874027
• UDI-Public: 08714729874027
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: 09/30/2025
• Device Model Number: 26928
• Device Catalogue Number: 26928
• Device Lot Number: 0026110378
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 03/19/2021
• Patient Sequence Number: 1