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 Patient Involvement (2645)
Date of Event	11/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was dislodged.A 6 x 40 x 130mm innova stent was selected for use.During preparation, the stent was removed from the packaging and pre-dilated.The stent then deployed and came off of the delivery system before it was able to be used inside the patient.Another stent was used to complete the procedure.There were no patient complications reported.
Event or Problem Description
It was reported that the stent was dislodged.A 6 x 40 x 130mm innova stent was selected for use.During preparation, the stent was removed from the packaging and pre-dilated.The stent then deployed and came off of the delivery system before it was able to be used inside the patient.Another stent was used to complete the procedure.There were no patient complications reported.Device evaluated by mfr: returned product consisted of an innova self-expanding stent system with the thumbwheel protector.Visual examination revealed a kink at the nosecone.Kinks at the nosecone are usually caused by handling and/or packaging the product to be returned.The yellow thumbwheel protector is still attached but is on backwards.Microscopic examination did not reveal any damages.The stent did not return with the device.There is blood present in the inner liner.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: 8116986
• Report Number: 2134265-2018-63295
• Device Sequence Number: 13845352
• Product Code: NIP
• UDI-Device Identifier: 08714729873990
• UDI-Public: 08714729873990
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/12/2018

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: 08/31/2019
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0019585102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1