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

Model Number 26928

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2018

Event Type  malfunction  

Event Description

It was reported that the stent became stuck on the guidewire.A 7x100x130 innova self expanding stent was selected for use for a superficial femoral artery (sfa) interventional procedure.The stent was attempted to deploy, however, it became stuck on a magic torque guidewire.The physician then removed the stent and delivery system, along with the wire out of the patient through the sheath.The physician had to regain wire access and the procedure was completed with another device.There were no patient complications reported and the patient's status post procedure was stable.The outer shaft, middle shaft and the remainder of the device were checked for damage.There was a kink at the nosecone.No wire was in the device when returned.A.035 amplatz test guidewire was inserted into the device and the wire transcended through the device with no hesitations or restrictions until the kink at the nose cone where a restriction was felt.With applied pressure the wire transcended through the rest of the device.The stent was not returned.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7852181
• MDR Text Key: 119496421
• Report Number: 2134265-2018-60496
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729874119
• UDI-Public: 08714729874119
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2021
• Device Model Number: 26928
• Device Catalogue Number: 26928
• Device Lot Number: 0022224956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2018
• 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