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	03/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that inadvertent stent deployment occurred.A 8x20x130 innova stent was selected for a procedure.During preparation, the stent deployed from the delivery system outside of the patient.The procedure was completed with an 8x40 innova stent successfully.There were no patient complications.
Event or Problem Description
It was reported that inadvertent stent deployment occurred.A 8x20x130 innova stent was selected for a procedure.During preparation, the stent deployed from the delivery system outside of the patient.The procedure was completed with an 8x40 innova stent successfully.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an innova self-expanding stent system.Visual examination revealed that the rack appeared to be fully deployed and measured approximately 13cm from the handle to the knob.The stent did not return with the device.The yellow thumbwheel protector was missing and did not return with the device.There were kinks on the outer sheath at the nosecone and 56.2cm from the nosecone.The proximal inner was kinked 15mm from the distal end of the proximal inner.The inner lumen was kinked 36mm from the tip.Microscopic examination revealed no additional damages.There was blood present in the middle sheath, proximal inner, and 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: 8454104
• Report Number: 2134265-2019-02963
• Device Sequence Number: 16198847
• Product Code: NIP
• UDI-Device Identifier: 08714729874164
• UDI-Public: 08714729874164
• 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): 04/04/2019

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: 09/30/2019
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0019736002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 04/04/2019
• Patient Sequence Number: 1