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	12/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent inadvertently deployed.A 6x40x130 innova device was selected for a stenting procedure in the right internal iliac.During the procedure, the innova failed to advance through the sheath.The device was removed and inspected.It was noted that the leading edge of the stent was exposed.The device was removed completely and another of the same device was used to complete the procedure.There were no patient complications reported.
Event or Problem Description
It was reported that the stent inadvertently deployed.A 6x40x130 innova device was selected for a stenting procedure in the right internal iliac.During the procedure, the innova failed to advance through the sheath.The device was removed and inspected.It was noted that the leading edge of the stent was exposed.The device was removed completely and another of the same device was used to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
Device analysis by mfr: returned product consisted of an innova self-expanding stent system with the thumbwheel protector still in the manufacturer position.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed kinks on the sheath at the nosecone, 33.9cm and 72.3cm from the nosecone.There is a kink on the middle sheath 3cm from the distal end of the middle sheath.Microscopic examination revealed that there is buckling on the middle sheath 2mm from the distal end of the middle sheath.The distal end of the middle sheath is damaged, and the tip is damaged.The stent did not return with the device.There is blood present inside the middle sheath.The device was functionally tested by inserting a 0.035" guidewire into a 6f introducer sheath.The device was then tracked along the guidewire thru the introducer sheath and there was some slight resistance felt from the buckling.

• 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: 8214639
• Report Number: 2134265-2018-64546
• Device Sequence Number: 11329527
• Product Code: NIP
• UDI-Device Identifier: 08714729873990
• UDI-Public: 08714729873990
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 02/06/2019

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: 05/16/2021
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0022131514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 02/06/2019
• Patient Sequence Number: 1