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

Model Number	26928
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	01/16/2019
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died during procedure.The patient presented with occlusion of the aorta and bilateral iliac arteries.The target lesion was 100% stenosed.Multiple balloons were used to dilate an open channel in the occlusion, including a charger balloon.There were no reported issues with the use of the charger balloon.After dilation, the renal artery was first stented with a non-bsc stent.The aorta was then stented with a non-bsc stent.The ostial common iliac was stented with non-bsc covered stents.These stents were extended in the iliac region using three 8x100x75mm innova stents, and one 7x80x75mm innova stent.There were no reported issues observed during the deployment of the innova stents.However, the patient ultimately died during the procedure.
Event or Problem Description
It was reported that the patient died during procedure.The patient presented with occlusion of the aorta and bilateral iliac arteries.The target lesion was 100% stenosed.Multiple balloons were used to dilate an open channel in the occlusion, including a charger balloon.There were no reported issues with the use of the charger balloon.After dilation, the renal artery was first stented with a non-bsc stent.The aorta was then stented with a non-bsc stent.The ostial common iliac was stented with non-bsc covered stents.These stents were extended in the iliac region using three 8x100x75mm innova stents, and one 7x80x75mm innova stent.There were no reported issues observed during the deployment of the innova stents.However, the patient ultimately died during the procedure.It was further reported that the patient died due to a perforation in the right common iliac.The patient died during procedure.The cath lab manager reported that no bsc products were attributed to the cause of death.

• 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: 8336355
• Report Number: 2134265-2019-01069
• Device Sequence Number: 16549171
• Product Code: NIP
• UDI-Device Identifier: 08714729873846
• UDI-Public: 08714729873846
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2021
• Device Model Number: 26928
• Device Catalogue Number: 26928
• Device Lot Number: 22423515
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 02/19/2019
• 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: Death