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

Model Number	26924
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was partially deployed when the packaging was opened.An 6mm x 80mm x 130cm innova vascular self-expanding stent was chosen for a superficial femoral artery (sfa) angioplasty and stent placement, to treat peripheral artery disease.During preparation, the packaging was opened and the stent was partially deployed.The device was disposed of and another innova was used successfully.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: 11761330
• Report Number: 2134265-2021-05534
• Device Sequence Number: 4634971
• Product Code: NIP
• UDI-Device Identifier: 08714729874010
• UDI-Public: 08714729874010
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2021

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: 06/10/2025
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0025586989
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/03/2021
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 77