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

Model Number	26924
Medical Device Problem Codes	Difficult to Insert (1316); Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent prematurely deployed.A 6x80x130 innova self expanding stent was selected for use for a chronic total occlusion (cto) of the superficial femoral artery (sfa) stenting procedure.The innova delivery system was advanced over a non-bsc guidewire inside a non-bsc sheath to the target lesion.There were difficulties encountered entering the sheath.The physician realized on fluoro that something was not right before the physician attempted deploy the stent.The catheter and stent were removed from the patient and it was noted stent was partially prematurely deployed without expansion.The procedure was completed with another innova stent without any issues.There were no 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: 9162423
• Report Number: 2134265-2019-12040
• Device Sequence Number: 2346835
• Product Code: NIP
• UDI-Device Identifier: 08714729874010
• UDI-Public: 08714729874010
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2019

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: 06/10/2022
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0023930916
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR