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

Model Number 26924

Device Problems Difficult to Insert (1316); Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2019

Event Type  malfunction  

Event Description

It was reported that the stent prematurely deployed.A 6x80x130 innova self expanding stent was selected for use for a chronic total occlusion (cto) of the superficial femoral artery (sfa) stenting procedure.The innova delivery system was advanced over a non-bsc guidewire inside a non-bsc sheath to the target lesion.There were difficulties encountered entering the sheath.The physician realized on fluoro that something was not right before the physician attempted deploy the stent.The catheter and stent were removed from the patient and it was noted stent was partially prematurely deployed without expansion.The procedure was completed with another innova stent without any issues.There were no patient complications reported.

• Brand Name: INNOVA VASCULAR
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9162423
• MDR Text Key: 161855247
• Report Number: 2134265-2019-12040
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729874010
• UDI-Public: 08714729874010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2022
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0023930916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR