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	08/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent deployed inadvertently upon advancing it over a wire.A 6x60x130 innova vascular stent was selected for use during a procedure located in the patient's left superficial femoral artery (sfa).While physician was advancing over a rosen wire, approximately 1/3 of the stent partially deployed.This occurred outside of the patient's body.The cause of this issue is believed to be related to the device sticking to the wire.The stent and wire were removed and replaced with another wire and innova.The procedure was completed without any complication.No patient impact.
Event or Problem Description
It was reported that the stent deployed inadvertently upon advancing it over a wire.A 6x60x130 innova vascular stent was selected for use during a procedure located in the patient's left superficial femoral artery (sfa).While physician was advancing over a rosen wire, approximately 1/3 of the stent partially deployed.This occurred outside of the patient's body.The cause of this issue is believed to be related to the device sticking to the wire.The stent and wire were removed and replaced with another wire and innova.The procedure was completed without any complication.No patient impact.Device evaluated by mfr: returned product consisted of an innova self-expanding stent delivery system.The outer sheath, mid-shaft, and the remainder of the device were checked for damage.Visual examination showed a kink at the nosecone.No other damage was noticed.The yellow thumbwheel lock was intact on the device.The pull handle was in the start position.The customer site stated the stent started to deploy as the device was being loaded onto the guidewire.A.035 test guidewire was inserted into the device to try and duplicate any guidewire stickiness the customer stated they observed.The guidewire transcended through the shaft with no restrictions.There was a slight hesitation when the guidewire reached the kink at the nosecone.The stent was 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: 7862210
• Report Number: 2134265-2018-60844
• Device Sequence Number: 1980587
• Product Code: NIP
• UDI-Device Identifier: 08714729874003
• UDI-Public: 08714729874003
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/25/2018

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: 05/15/2021
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0022125803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1