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

Model Number	26924
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	09/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event : patient was reported to be in late 50s.
Event or Problem Description
It was reported that there was acute stent thrombosis upon implantation.Prior to the procedure the patient was administered 4000 units of heparin.The lesion was located in the proximal part of the superficial femoral artery (sfa).Following pre-dilation, a 6 x 40 x 130 innova stent was deployed without issues.The patient developed clot immediately.The physician was not aware that the patient was heparin resistant.Imaging showed that the stent was completely clogged and even beyond the stent there was clot.An additional 12000 untis of heparin was administered and that did not resolve the clots.Tpa was directly administered into the site which cleared some of the clots.A bsc angiojet solent catheter was used to clear the remaining clots.The clots were cleared and the patient is fine.

• 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: 7975384
• Report Number: 2134265-2018-61996
• Device Sequence Number: 1214033
• Product Code: NIP
• UDI-Device Identifier: 08714729873990
• UDI-Public: 08714729873990
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2021
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0021816009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention