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

Model Number	26924
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported stent placement difficulties occurred.A stenting procedure was being performed in the superficial femoral artery (sfa) ostium using a retrograde popliteal approach.As the innova 6 x 20 x 130 stent was positioned and deployment initiated, the stent moved forward and partially covered the profunda artery.It was noted the physician thought the device was being held steady in position and was surprised that the stent moved forward.The stent was post dilated and the procedure was completed with no adverse effect to the patient outcome.It was noted there was no need to do anything further, the physician just didn't like the final position of the stent.Device evaluated by manufacturer: returned product consisted of an innova self-expanding stent delivery system (sds).A visual examination identified a kink at the nosecone.The stent was not returned.Per the customers statement the stent was deployed in the patient.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: 7976124
• Report Number: 2134265-2018-61997
• Device Sequence Number: 19225456
• Product Code: NIP
• UDI-Device Identifier: 08714729873983
• UDI-Public: 08714729873983
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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: 06/11/2020
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0020754073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1