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

Model Number	26928
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent became stuck on the guidewire.A 7x100x130 innova self expanding stent was selected for use for a superficial femoral artery (sfa) interventional procedure.The stent was attempted to deploy, however, it became stuck on a magic torque guidewire.The physician then removed the stent and delivery system, along with the wire out of the patient through the sheath.The physician had to regain wire access and the procedure was completed with another device.There were no patient complications reported and the patient's status post procedure was stable.The outer shaft, middle shaft and the remainder of the device were checked for damage.There was a kink at the nosecone.No wire was in the device when returned.A.035 amplatz test guidewire was inserted into the device and the wire transcended through the device with no hesitations or restrictions until the kink at the nose cone where a restriction was felt.With applied pressure the wire transcended through the rest of the device.The stent was not returned.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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: 7852181
• Report Number: 2134265-2018-60496
• Device Sequence Number: 1703269
• Product Code: NIP
• UDI-Device Identifier: 08714729874119
• UDI-Public: 08714729874119
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2018

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: 06/07/2021
• Device Model Number: 26928
• Device Catalogue Number: 26928
• Device Lot Number: 0022224956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1