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

Model Number	26924
Medical Device Problem Codes	Entrapment of Device (1212); Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent inadvertently deployed when attempting to remove it from being stuck to the wire.A 6x60x130 innova vascular stent was selected for use for a stenting procedure in the superficial femoral artery (sfa).During preparation, outside of the patient's body, the physician attempted to load the stent over an unspecified.035 guidewire but the stent became stuck on the guidewire.When the physician attempted to pull the stent off of the wire, the stent started to inadvertently deploy.It partially deployed.Another innova vascular stent was used to complete the procedure.There were no patient complications reported.
Event or Problem Description
It was reported that the stent inadvertently deployed when attempting to remove it from being stuck to the wire.A 6x60x130 innova vascular stent was selected for use for a stenting procedure in the superficial femoral artery (sfa).During preparation, outside of the patient's body, the physician attempted to load the stent over an unspecified.035 guidewire but the stent became stuck on the guidewire.When the physician attempted to pull the stent off of the wire, the stent started to inadvertently deploy.It partially deployed.Another innova vascular stent was used to complete the procedure.There were no patient complications reported.Device evaluated by mfr: the outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink at the nosecone.Kinks at the nosecone most likely occurs from handling, when it is packaged to be returned for investigation.The yellow thumbwheel protector is still attached but is on backwards.The pull grip is pulled 33mm out and there is blood present in the inner liner.The stent was completely outside of the device.Microscopic examination revealed that there is foreign material (fm) present on the stent.An amplatz super stiff.035 guidewire was used and the guidewire could pass through the entire device.Inspection of the remainder of the device presented 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: 8117874
• Report Number: 2134265-2018-63323
• Device Sequence Number: 11205105
• Product Code: NIP
• UDI-Device Identifier: 08714729874003
• UDI-Public: 08714729874003
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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: 11/27/2020
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0021432470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1