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

Model Number 26924

Device Problem Premature Activation (1484)

Patient Problem No Patient Involvement (2645)

Event Date 11/09/2018

Event Type  malfunction  

Event 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 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
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8116986
• MDR Text Key: 128806004
• Report Number: 2134265-2018-63295
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729873990
• UDI-Public: 08714729873990
• Combination Product (y/n): N
• PMA/PMN Number: P140028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1