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

Model Number	26926
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent partly inadvertently deployed.A 6 x 150 x 130 innova was selected for a superficial femoral artery stenting procedure.Upon removal from the package, it was observed that the stent was partially deployed even though the thumbwheel lock was still in place.The device was not inserted into the patient.Another of the same device was used to complete the case.There were no patient complications.
Event or Problem Description
It was reported that the stent partly inadvertently deployed.A 6 x 150 x 130 innova was selected for a superficial femoral artery stenting procedure.Upon removal from the package, it was observed that the stent was partially deployed even though the thumbwheel lock was still in place.The device was not inserted into the patient.Another of the same device was used to complete the case.There were no patient complications.Returned product consisted of an innova self-expanding stent delivery system (sds).The outer sheath, mid-shaft, and the remainder of the device were checked for damage.Visual examination showed no damage on the shaft.The stent was partially deployed 2.2cm from the distal end of the markerband.The pull handle was pulled approximately 1.7cm from the handle.With the pull handle moved from the start position this is consistent with the handle being pulled.The yellow thumbwheel lock was returned on the device.With 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: 7981354
• Report Number: 2134265-2018-62079
• Device Sequence Number: 13736069
• Product Code: NIP
• UDI-Device Identifier: 08714729874041
• UDI-Public: 08714729874041
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 11/16/2018

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: 06/04/2021
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0022206502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 11/16/2018
• Patient Sequence Number: 1