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

Model Number	26928
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: over 60 years old.
Event or Problem Description
It was reported that the stent prematurely deployed.A 5mm x 100mm x 130cm innova was selected for use in a stenting procedure in the left superficial femoral artery (sfa).During the procedure, the stent began to deploy before it was in position.The deployment safety tool was still on.The device was removed without issue.The procedure was completed with another 5mm x 100mm innova.No patient complications were reported, and it was a good outcome.
Additional Manufacturer Narrative
A2: age at time of event - over 60 years old.
Event or Problem Description
It was reported that the stent prematurely deployed.A 5mm x 100mm x 130cm innova was selected for use in a stenting procedure in the left superficial femoral artery (sfa).During the procedure, the stent began to deploy before it was in position.The deployment safety tool was still on.The device was removed without issue.The procedure was completed with another 5mm x 100mm innova.No patient complications were reported, and it was a good outcome.It was further reported that: a contralateral approach was taken to access the lesion and the safety lock was still in place prior to positioning in the lesion.Exposing the stent prior to deployment was performed as directed.

• 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: 11317213
• Report Number: 2134265-2021-01585
• Device Sequence Number: 790611
• Product Code: NIP
• UDI-Device Identifier: 08714729873938
• UDI-Public: 08714729873938
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/04/2021

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: 26928
• Device Catalogue Number: 26928
• Device Lot Number: 0026284304
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/05/2021
• Patient Sequence Number: 1