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 Consequences Or Impact To Patient (2199)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned product consisted of an innova self-expanding stent system with the yellow thumbwheel protector still in the manufactured position.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the sheath is wavy in appearance when placed on a flat surface.The stent is partially deployed approximately 8.5mm from the distal end of the middle sheath.The middle sheath is no longer sitting on top of the proximal end of the tip.Microscopic examination revealed no additional damages.There is blood in the middle sheath.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage to the sheath that may have contributed to the premature deployment.
Event or Problem Description
It was reported that the stent prematurely deployed.A 7x60x130 innova self expanding stent was selected for a percutaneous transluminal angioplasty (pta) procedure on a calcified and tortuous vasculature.The innova delivery system was advanced over the wire to the target lesion.The physician wanted to reposition the device, and during this attempt the stent began to prematurely deploy, approximately 10mm of the stent became exposed.The entire delivery catheter with the partially exposed stent was removed over the wire from the patient.There were no patient complications.The procedure was completed with a 7x80 innova device.

• 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: 8790159
• Report Number: 2134265-2019-08032
• Device Sequence Number: 1832466
• Product Code: NIP
• UDI-Device Identifier: 08714729874096
• UDI-Public: 08714729874096
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 07/15/2019

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: 04/28/2022
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0023708218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1