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

Model Number	26926
Medical Device Problem Codes	Premature Activation (1484); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent shortened after deployment.A 6x150mm innova self expanding stent was selected for use for an atherectomy and percutaneous transluminal angioplasty procedure in the heavily calcified, and 87% stenosed, right superficial femoral artery (sfa).After pre-dilation using a charger balloon, the innova stent was used.The physician had difficulty maintaining a good support rail, and there was some difficulty deploying the stent.After the stent was deployed, the stent was observed to shorten from 150mm to about 80mm.The procedure was completed using another innova stent to cover the lesion.There were no patient complications reported, and the patient's status was reported as fine.
Event or Problem Description
It was reported that the stent shortened after deployment.A 6x150mm innova self expanding stent was selected for use for an atherectomy and percutaneous transluminal angioplasty procedure in the heavily calcified, and 87% stenosed, right superficial femoral artery (sfa).After pre-dilation using a charger balloon, the innova stent was used.The physician had difficulty maintaining a good support rail, and there was some difficulty deploying the stent.After the stent was deployed, the stent was observed to shorten from 150mm to about 80mm.The procedure was completed using another innova stent to cover the lesion.There were no patient complications reported, and the patient's status was reported as fine.It was further reported that the difficulties during deployment of the stent were due to the stent prematurely deploying in the lesion.

• 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: 8367438
• Report Number: 2134265-2019-01489
• Device Sequence Number: 1599673
• Product Code: NIP
• UDI-Device Identifier: 08714729874041
• UDI-Public: 08714729874041
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 22874623
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 03/01/2019
• 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: Other